U.S. patent application number 11/178044 was filed with the patent office on 2006-04-13 for apparatus for collecting information.
Invention is credited to Chris Carpenter, Lawrence Newman, Steven Elliot Stupp.
Application Number | 20060080059 11/178044 |
Document ID | / |
Family ID | 35839739 |
Filed Date | 2006-04-13 |
United States Patent
Application |
20060080059 |
Kind Code |
A1 |
Stupp; Steven Elliot ; et
al. |
April 13, 2006 |
Apparatus for collecting information
Abstract
An apparatus, and related method, for collecting information,
such as that associated with one or more variables, is described.
The apparatus may include at least one processor, at least one
memory, and at least one program module. The program module may be
stored in the memory and may be configurable to be executed by the
processor. The program module may include instructions for a set of
pre-determined questions, instructions for asking, one or more
times during a time interval, a subset of pre-determined questions
in the set of pre-determined questions, instructions for receiving,
one or more times during the time interval, answers to the subset
of pre-determined questions, and instructions for receiving
configuration instructions. The configuration instructions may
select the subset of pre-determined questions that are asked.
Inventors: |
Stupp; Steven Elliot; (San
Carlos, CA) ; Carpenter; Chris; (Sunnyvale, CA)
; Newman; Lawrence; (Katonah, NY) |
Correspondence
Address: |
Steven Stupp
918 Woodland Ave.
San Carlos
CA
94070
US
|
Family ID: |
35839739 |
Appl. No.: |
11/178044 |
Filed: |
July 8, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60601480 |
Aug 14, 2004 |
|
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|
60591300 |
Jul 27, 2004 |
|
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60587003 |
Jul 10, 2004 |
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Current U.S.
Class: |
702/120 |
Current CPC
Class: |
G16H 20/60 20180101;
G16H 50/20 20180101; G16H 50/70 20180101; G16H 10/20 20180101; G06F
17/18 20130101; Y10S 128/92 20130101; A61B 5/0002 20130101; G16H
50/30 20180101; A61B 5/7267 20130101; G16H 50/50 20180101 |
Class at
Publication: |
702/120 |
International
Class: |
G01R 27/28 20060101
G01R027/28 |
Claims
1. An apparatus for collecting information associated with
migraines, comprising: at least one processor; at least one memory;
and at least one program module, the program module stored in the
memory and configurable to be executed by the processor, the
program module including: instructions for a set of pre-determined
questions; instructions for asking, one or more times during a time
interval, a subset of pre-determined questions in the set of
pre-determined questions; instructions for receiving, one or more
times during the time interval, answers to the subset of
pre-determined questions; and instructions for receiving
configuration instructions, wherein the configuration instructions
select the subset of pre-determined questions that are asked.
2. The apparatus of claim 1, wherein the instructions for asking
include displaying the subset of pre-determined questions on a
display, and wherein a respective pre-selected answer is displayed
for each question in at least a plurality of pre-determined
questions in the subset of pre-determined questions such that
answering the respective pre-determined question only involves
selection if the respective answer to the respective pre-determined
question is different than the respective pre-selected answer.
3. The apparatus of claim 1, wherein the respective pre-selected
answer for each pre-determined question in at least the plurality
of pre-determined questions is selected in accordance with an
answer history.
4. The apparatus of claim 1, wherein the respective pre-selected
answer for each pre-determined question in at least the plurality
of pre-determined questions corresponds to a respective default
answer.
5. The apparatus of claim 1, wherein the set of pre-determined
questions correspond to one or more migraine triggers.
6. The apparatus of claim 5, wherein the one or more migraine
triggers at least in part induce a migraine in at least one
individual if at least the one individual is exposed to one or more
of the migraine triggers.
7. The apparatus of claim 1, wherein the subset of pre-determined
questions is varied during the time interval in accordance with the
configuration instructions.
8. The apparatus of claim 1, wherein the apparatus is capable of
wireless communication.
9. The apparatus of claim 1, wherein the apparatus comprises a
cellular telephone.
10. The apparatus of claim 1, wherein the instructions for
receiving the configuration instructions includes use of an
electronic messaging technique selected from a Short Message
Service (SMS) and email.
11. The apparatus of claim 1, the program module further including
instructions for only transmitting answers to the subset of
pre-determined questions using an electronic messaging technique
selected from a Short Message Service (SMS) and email, and wherein
the instructions for receiving configuration instructions include
only receiving configuration instructions using the electronic
messaging technique.
12. The apparatus of claim 1, the program module further including
instructions for transmitting answers to at least the subset of
pre-determined questions.
13. The apparatus of claim 12, wherein the instructions for
transmitting answers include only transmitting answers using an
electronic messaging technique selected from a Short Message
Service (SMS) and email.
14. The apparatus of claim 1, wherein a plurality of the subset of
pre-determined questions comprise categorical questions.
15. The apparatus of claim 14, wherein the categorical questions
further include ordered categorical questions.
16. The apparatus of claim 1, wherein the set of pre-determined
questions include pre-determined questions corresponding to
premonitory symptoms during a prodrome phase corresponding to one
or more migraines.
17. The apparatus of claim 1, wherein the set of pre-determined
questions include pre-determined questions corresponding to
deviations from normal behavior while an individual is awake.
18. The apparatus of claim 1, wherein the set of pre-determined
questions include pre-determined questions corresponding to
deviations from normal dietary behavior for an individual.
19. The apparatus of claim 1, wherein the instructions for
receiving answers to the subset of pre-determined questions include
a use of voice recognition.
20. A method of collecting information associated with migraines,
comprising: transmitting configuration instructions to a device,
wherein the device is configured with a set of pre-determined
questions, and wherein the configuration instructions select a
subset of pre-determined questions in the set of pre-determined
questions; asking, one or more times during a time interval, the
subset of pre-determined questions; and receiving, one or more
times during a time interval, answers to the subset of
pre-determined questions.
21. The method of claim 20, further comprising providing an
individual with the device.
22. A computer-program product for use in conjunction with a
computer system, the computer-program product comprising a
computer-readable storage medium and a computer-program mechanism
embedded therein for collecting information associated with
migraines, the computer-program mechanism including: instructions
for a set of pre-determined questions; instructions for asking, one
or more times during a time interval, a subset of pre-determined
questions in the set of pre-determined questions; instructions for
receiving, one or more times during a time interval, answers to the
subset of pre-determined questions; and instructions for receiving
configuration instructions, wherein the configuration instructions
select the subset of pre-determined questions that are asked.
23. An apparatus for collecting information associated with
migraines, comprising: at least one computational means; at least
one storage means; and at least one program module mechanism, the
program module mechanism stored in at least the storage means and
configurable to be executed by at least the computational means, at
least the program module mechanism including: instructions for a
set of pre-determined questions; instructions for asking, one or
more times during a time interval, a subset of pre-determined
questions in the set of pre-determined questions; instructions for
receiving, one or more times during a time interval, answers to the
subset of pre-determined questions; and instructions for receiving
configuration instructions, wherein the configuration instructions
select the subset of pre-determined questions that are asked.
24. A method of collecting information associated with migraines,
comprising: providing a subset of pre-determined questions in a set
of pre-determined questions to a client computer one or more times
during a time interval; and receiving answers to the subset of
pre-determined questions from the client computer one or more times
during the time interval, wherein the subset of pre-determined
questions is varied during the time interval.
25. A method of collecting information associated with migraines,
comprising: receiving a subset of pre-determined questions in a set
of pre-determined questions from a server one or more times during
a time interval; and transmitting answers to the subset of
pre-determined questions to the server one or more times during the
time interval, wherein the subset of pre-determined questions is
varied during the time interval.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 119(e) to
U.S. Provisional Application Ser. No. 60/601,480, "Medical
Informatics System," filed on Aug. 14, 2004, to U.S. Provisional
Application Ser. No. 60/591,300, entitled "Healthcare
Provider-Patient Interaction Management System," filed on Jul. 27,
2004, and to U.S. Provisional Application Ser. No. 60/587,300,
entitled "Medical Informatics System," filed on Jul. 10, 2004, the
contents of each of which are herein incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to an apparatus, and
related methods, for processing data, and more specifically, for
collecting information and determining statistical
relationships.
BACKGROUND OF THE INVENTION
[0003] Statistical learning problems may be categorized as
supervised or unsupervised. In supervised learning, the goal is to
predict an output based on a number of input factors or variables
(henceforth, referred to as variables), where a prediction rule is
learned from a set of examples (referred to as training examples)
each showing the output for a respective combination of variables.
In unsupervised learning, the goal is to describe associations and
patterns among a set of variables without the guidance of a
specific output. An output may be predicted after the associations
and patterns have been determined. These categories are illustrated
in FIGS. 1A and 1B, which show data points as a function of weight
110 and height 112. In unsupervised learning 100 in FIG. 1A, the
data may be described by input variables weight 110 and height 112
without any additional information (e.g., labels) that could help
to find patterns in the data. Patterns in the data may be found by
learning that there are two distinguished "clusters" of data points
(represented by circles or decision boundaries 114 around them).
Within each cluster, data in group A 116 or group B 118 are highly
similar (i.e., close) and between clusters data are highly
dissimilar (i.e., further away). When a new data point, i.e.,
combination of the input variables becomes available, it may be
categorized as similar to and thus a potential member of one of the
clusters that have been discovered, or as an outlier or as a member
of a new cluster.
[0004] In supervised learning 130 in FIG. 1B, additional
information about the data is available. The data points are
labeled as Dutch 132 (white circles) or American 134 (filled-black
circles). This extra information is exactly the output one wants to
predict for future data. Having it available for the training data
or examples allows predictive decision boundary 136 to be
determined. In general, statistical learning involves finding a
statistical model that explains the observed data that may be used
to analyze new data, e.g., learning a weighted combination of
numerical variables from labeled training data to predict a class
or classification for a new combination of variables. Determining a
model to predict quantitative outputs (continuous variables) is
often referred to as regression. Determining a model to predict
qualitative data (discrete categories, such as `yes` or `no`) is
often referred to as classification.
[0005] Developing models for statistical learning problems
involving longitudinal data, in which a time series of observations
are collected over a period of time, poses several challenges,
including those associated with collecting the data efficiently and
accurately. Analysis of the data may also be problematic, in
particular, for a class of problems where variables associated with
time-varying phenomena that have discrete events or epochs, each
epoch having a characteristic onset time (henceforth referred to as
a temporal onset), are sought. For example, in such problems there
may be limited data and a plurality of potential variables to be
screened. The analysis, therefore, may be underdetermined. In
addition, the potential variables may not be independent from one
another and/or samples of the potential variables may not have a
corresponding probability distribution (for example, a normal
distribution).
[0006] There is a need, therefore, for an analysis technique to
address the challenges described above and to determine variables
associated with time-varying phenomena having discrete epochs.
SUMMARY OF THE INVENTION
[0007] An apparatus, and related method, for collecting
information, such as that associated with one or more variables, is
described. The apparatus may include at least one processor, at
least one memory, and at least one program module. The program
module may be stored in the memory and may be configurable to be
executed by the processor. The program module may include
instructions for a set of pre-determined questions, instructions
for asking, one or more times during a time interval, a subset of
pre-determined questions in the set of pre-determined questions,
instructions for receiving, one or more times during the time
interval, answers to the subset of pre-determined questions, and
instructions for receiving configuration instructions. The
configuration instructions may select the subset of pre-determined
questions that are asked.
[0008] The instructions for asking may include displaying the
subset of pre-determined questions on a display. A respective
pre-selected answer may be displayed for each question in at least
a plurality of pre-determined questions in the subset of
pre-determined questions such that answering the respective
pre-determined question only involves selection if the respective
answer to the respective pre-determined question is different than
the respective pre-selected answer. The respective pre-selected
answer for each pre-determined question in at least the plurality
of pre-determined questions may be selected in accordance with an
answer history. The respective pre-selected answer for each
pre-determined question in at least the plurality of pre-determined
questions may correspond to a respective default answer.
[0009] The subset of pre-determined questions may be varied during
the time interval in accordance with the configuration
instructions. In some embodiments, the set of pre-determined
questions and/or the one or more variables may correspond to one or
more migraine triggers. One or more of the migraine triggers may at
least in part induce a migraine in at least one individual if at
least the one individual is exposed to one or more of the migraine
triggers.
[0010] In some embodiments, the set of pre-determined questions may
correspond to a disease and the one or more variables may at least
in part induce an episodic increase in a severity of one or more
symptoms associated with the disease for at least the one
individual. The disease may include a form of arthritis, rheumatoid
arthritis, joint disease, an auto-immune disorder, an
immune-related disorder, an inflammatory disease, lupus, thyroid
disease, gout, diabetes, chronic fatigue syndrome, insomnia,
depression, a psychological disease, gastrointestinal disease,
colitis, ulcerative colitis, inflammatory bowel disease, Crohn's
disease, candida, celiac disease, irritable bowel syndrome, one or
more food allergies, one or more food sensitivities, morning
sickness, menstrual cramps, chronic pain, back pain, facial pain,
fibromyalgia, asthma, migraines, abdominal migraines, cyclic
vomiting syndrome, cluster headaches, chronic headaches, tension
headaches, another type of headache, seizures, epilepsy,
neurodermatitis, acne, psoriasis, adiposity, hypertonia, heart
disease, hypertension, cardiovascular disease, arteriosclerosis, a
form of cancer and/or acquired immune deficiency syndrome.
[0011] The apparatus may be capable of wireless communication. The
apparatus may include a cellular telephone.
[0012] The instructions for receiving answers to the subset of
pre-determined questions may include a use of voice recognition.
The instructions for receiving the configuration instructions may
include receiving the configuration instructions using electronic
messages, such as Short Message Service (SMS) messages and/or email
messages. The program module may include instructions for
transmitting answers to at least the subset of pre-determined
questions. In some embodiments, the instructions for receiving
configuration instructions may include only receiving configuration
instructions using SMS messages and/or email messages. In some
embodiments, the instructions for transmitting answers may include
only transmitting answers using SMS messages and/or email
messages.
[0013] A plurality of the subset of pre-determined questions may
include categorical questions. The categorical questions may
include ordered categorical questions.
[0014] In some embodiments, the set of pre-determined questions may
include pre-determined questions corresponding to premonitory
symptoms during a prodrome phase corresponding to one or more
migraines. The set of pre-determined questions may include
pre-determined questions corresponding to deviations from normal
behavior while a first individual is awake. The set of
pre-determined questions may include pre-determined questions
corresponding to deviations from normal dietary behavior for the
first individual. The set of pre-determined questions may
correspond to the disease.
[0015] In another embodiment, a process of collecting information,
such as that associated with the one or more variables, is
described. A second individual may be provided with a device. The
device may be configured with the set of pre-determined questions.
Configuration instructions may be transmitted to the device. The
configuration instructions may select a subset of pre-determined
questions in the set of pre-determined questions. The subset of
pre-determined questions may be asked one or more times during the
time interval. Answers to the subset of pre-determined questions
may be received one or more times during the time interval.
[0016] In another embodiment, a process of collecting information,
such as that associated with the one or more variables, is
described. A third data stream including configuration instructions
may be received. The configuration instructions may select the
subset of pre-determined questions in the set of pre-determined
questions corresponding to the one or more association variables. A
fourth data stream including answers to the subset of
pre-determined questions may be transmitted one or more times
during the time interval.
[0017] In another embodiment, a process of collecting information,
such as that associated with the one or more variables, is
described. The third data stream including configuration
instructions may be transmitted. The configuration instructions may
select the subset of pre-determined questions in the set of
pre-determined questions corresponding to the one or more
association variables. The fourth data stream including answers to
the subset of pre-determined questions may be received one or more
times during the time interval.
[0018] In another embodiment, a system for collecting information,
such as that associated with the one or more variables, is
described. The system may include a server and a client computer
coupled to the server. The server may provide the subset of
pre-determined questions in the set of pre-determined questions to
the client computer one or more times during the time interval. The
client computer may transmit answers to the subset of
pre-determined questions to the server one or more times during the
time interval. The subset of pre-determined questions may be varied
during the time interval. The providing of the subset of
pre-determined questions may include instructions that are rendered
by a browser in the client computer.
[0019] In another embodiment, a process of collecting information,
such as that associated with the one or more variables, is
described. The subset of pre-determined questions in the set of
pre-determined questions may be provided to the client computer one
or more times during the time interval. Answers to the subset of
pre-determined questions may be received from the client computer
one or more times during the time interval. The subset of
pre-determined questions may be varied during the time
interval.
[0020] In another embodiment, a process of collecting information,
such as that associated with the one or more variables, is
described. The subset of pre-determined questions in the set of
pre-determined questions may be received from the server one or
more times during the time interval. Answers to the subset of
pre-determined questions may be transmitted to the server one or
more times during the time interval. The subset of pre-determined
questions may be varied during the time interval.
[0021] The disclosed embodiments reduce or eliminate the problems
described above and provide an analysis technique to determine
association variables associated with time-varying phenomena having
discrete epochs.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Additional objects and features of the invention will be
more readily apparent from the following detailed description and
appended claims when taken in conjunction with the drawings.
[0023] FIG. 1A is a block diagram illustrating an existing
unsupervised learning technique.
[0024] FIG. 1B is a block diagram illustrating an existing
supervised learning technique.
[0025] FIG. 2 is a block diagram illustrating an embodiment of a
system for collecting and analyzing data, and for providing
recommendations.
[0026] FIG. 3 is a block diagram illustrating an embodiment of a
server or computer.
[0027] FIG. 4 is a block diagram illustrating an embodiment of a
computer.
[0028] FIG. 5 is a block diagram illustrating an embodiment of a
device.
[0029] FIG. 6A is a block diagram illustrating an embodiment of a
questionnaire.
[0030] FIG. 6B is a block diagram illustrating an embodiment of a
questionnaire.
[0031] FIG. 6C is a block diagram illustrating an embodiment of a
questionnaire.
[0032] FIG. 7 is a block diagram illustrating an embodiment of
migraine triggers and sensitivity thresholds.
[0033] FIG. 8A is a block diagram illustrating an embodiment of a
questionnaire data structure.
[0034] FIG. 8B is a block diagram illustrating an embodiment of a
questionnaire.
[0035] FIG. 9A is a block diagram illustrating an embodiment of
determining a compound variable associated with events having
different temporal onsets.
[0036] FIG. 9B is a block diagram illustrating an embodiment of
determining compound variables.
[0037] FIG. 10 is a block diagram illustrating an embodiment of a
variable occurring during a duration of an event.
[0038] FIG. 11 is a block diagram illustrating an embodiment of
determining model complexity.
[0039] FIG. 12 is a block diagram illustrating an embodiment of
ranking variables.
[0040] FIG. 13 is a block diagram illustrating an embodiment of
associating one or more variables with one or more groups of
variables.
[0041] FIG. 14 is a block diagram illustrating an embodiment of a
signal processing circuit.
[0042] FIG. 15 is a flow diagram illustrating an embodiment of a
process for collecting information.
[0043] FIG. 16 is a flow diagram illustrating an embodiment of a
process for determining one or more association variables.
[0044] FIG. 17 is a flow diagram illustrating an embodiment of a
process for providing recommendation(s) and/or report(s).
[0045] FIG. 18 is a flow diagram illustrating an embodiment of a
process for providing one or more reports.
[0046] FIG. 19 is a block diagram illustrating an embodiment of a
questionnaire data structure.
[0047] FIG. 20 is a block diagram illustrating an embodiment of a
data structure.
[0048] Like reference numerals refer to corresponding parts
throughout the several views of the drawings.
DETAILED DESCRIPTION
[0049] Reference will now be made in detail to embodiments,
examples of which are illustrated in the accompanying drawings. In
the following detailed description, numerous specific details are
set forth in order to provide a thorough understanding of the
present invention. However, it will be apparent to one of ordinary
skill in the art that the present invention may be practiced
without these specific details. In other instances, well-known
methods, procedures, components, and circuits have not been
described in detail so as not to unnecessarily obscure aspects of
the embodiments.
[0050] Embodiments of one or more apparatuses, and related methods,
for collecting information and determining one or more association
variables are described. The information may be collected by asking
a subset of pre-determined questions in a set of pre-determined
questions one or more time during a data-collection time interval
using the one or more apparatuses.
[0051] The subset of pre-determined questions may be varied during
the data-collection time interval in accordance with configuration
instructions received by the one or more apparatuses. In some
embodiments, the configuration instructions correspond to
non-executable instructions. The configuration instructions may be
transmitted to the one or more apparatuses and answers to a subset
of the pre-determined questions, selected in accordance with the
configuration instructions, may be received from the one or more
apparatuses using SMS messages and/or email messages.
[0052] The subset of pre-determined questions may include
pre-selected answers that may be displayed for each question in at
least a plurality of pre-determined questions in the subset of
pre-determined questions. Answering a respective pre-determined
question may only involve selection if the respective answer to the
respective pre-determined question is different than the respective
pre-selected answer. The pre-selected answers may be selected in
accordance with an answer history for one or more individuals
and/or one or more groups of individuals. In some embodiments, the
pre-selected answers may correspond to one or more default
answers.
[0053] In some embodiments, at least one apparatus or device, such
as a personal digital assistant, a tablet computer, a Blackberry, a
cellular telephone, and/or a hand-held computer, containing the set
of pre-determined questions may be provided to at least one
individual. In some embodiments, at least the one individual may be
provided a memory card (such as a smart card, a subscriber identity
module or SIMS card, and/or a card having ROM, FLASH or other
memory) containing the set of pre-determined questions. In some
embodiments, at least one server may transmit instructions
corresponding to the subset of pre-determined questions to at least
one computer. A browser in at least the one computer may render the
instructions corresponding to the subset of pre-determined
questions. Communication with apparatuses, devices, computers,
and/or servers may occur via a network, such as the Internet (also
known as the World Wide Web), an Intranet, a local area network
(LAN), a wide area network (WAN), a metropolitan area network
(MAN), and/or a wireless network.
[0054] The one or more association variables may be determined
and/or identified, using one or more apparatuses, and/or the
related methods, in accordance with one or more statistical
relationships between one or more temporal onsets corresponding to
one or more events and patterns of occurrence of one or more
variables and/or one or more compound variables. The one or more
compound variables may be determined using one or more variables in
a set of variables. The one or more temporal onsets may include one
or more onset times and/or one or more onsets during one or more
time intervals.
[0055] A respective compound variable may correspond at least to a
pattern of occurrence of a first variable during a first time
interval preceding the one or more temporal onsets and a pattern of
occurrence of a second variable during a second time interval
preceding the one or more temporal onsets. The first time interval
and/or the second time interval may be offset in time from the one
or more temporal onsets. The first time interval may be different
than the second time interval. In some embodiments, the respective
compound variable may correspond to patterns of occurrence of three
of more variables during corresponding time intervals preceding the
one or more temporal onsets.
[0056] Contributions from presence and absence information in the
pattern of occurrence of the one or more compound variables may be
included when determining the one or more statistical
relationships. The pattern of occurrence for the respective
compound variable, such as the pattern of occurrence of the first
variable and the pattern of occurrence of the second variable, may
include presence and absence information.
[0057] The one or more statistical relationships may be determined
using a non-parametric analysis technique (which makes few
assumptions about an existence of a probability distribution
function, such as a normal distribution, corresponding to a
population from which samples are obtained, or regarding
independence of the variables and/or the compound variables) and/or
a supervised learning analysis technique. The analysis may perform
hypothesis testing to determine if the one or more temporal onsets
and the one or more compound variables and/or one or more variables
are statistically independent (or dependent) in accordance with a
statistical significance criterion. In the process, the analysis
may increase an effective signal-to-noise ratio in an
underdetermined problem (i.e., sparse sampling in a
multi-dimensional variable space) by restricting a number of local
fitting neighborhoods (i.e., a number of relevant variables and/or
compound variables).
[0058] The one or more compound variables may be ranked in
accordance with the one or more statistical relationships. The
variables in the set of variables may be ranked in accordance with
a number of occurrences of the variables in the compound variables
having respective statistical relationships that approximately
exceed the statistical confidence threshold corresponding to a
noise floor. The statistical confidence threshold may be selected
such that at least a subset of the ranking is approximately
stable.
[0059] One or more variables in the one or more compound variables,
such as the first variable and the second variable, may be
identified as the one or more association variables. Additional
association variables may be identified by associating the one or
more association variables with one or more groups of association
variables, including pre-determined groups of association
variables. One or more recommendations may be provided to at least
the one individual in accordance with the one or more association
variables. In some embodiments, at least the one individual may be
a healthcare provider (such as a physician, nurse, chiropractor,
and/or an associated staff member), a parent, a guardian, and/or an
individual that has a disease. The one or more recommendations may
be included in one or more reports.
[0060] The one or more association variables may, at least in part,
trigger, initiate, and/or precipitate the one or more events
(henceforth referred to as trigger). The one or more association
variables may directly or indirectly cause the one or more events.
Alternatively, the one or more association variables may not
directly or indirectly cause the one or more events. The one or
more association variables may enable the one or more events. To
make an analogy, in some embodiments the one or more association
variables may function as keys in one or more locks (receptors),
allowing a spring-loaded door (corresponding, for example, to a
biochemical predisposition) to open. Two or more association
variables may work in conjunction with one another, i.e., at least
the one individual may experience at least one event if at least
the one individual is exposed to two or more association variables
in close temporal proximity, in a temporal sequence and/or in an
ordered temporal sequence (i.e., a particular pattern of exposure
to two or more association variables). An effect of the association
variables may be cumulative. Exposure to a sufficient quantity of
the respective association variable may trigger the one or more
events, or exposure to quantities of two or more association
variables may trigger the one or more events. Be it cumulative
and/or cooperative, the respective association variable may
correspond to 5%, 10% 25%, 50% or more of a total trigger for the
one or more events. The one or more association variables may be
specific to an individual and/or a group of two or more
individuals. In some embodiments, the one or more events may
correspond to an episodic increase in a severity of one or more
symptoms associated with a disease, such as a chronic disease,
and/or a disease condition in at least the one individual.
[0061] The disease may include a form of arthritis, rheumatoid
arthritis, joint disease, an auto-immune disorder, an
immune-related disorder, an inflammatory disease, lupus, thyroid
disease, gout, diabetes, chronic fatigue syndrome, insomnia,
depression, a psychological disease, gastrointestinal disease,
colitis, ulcerative colitis, inflammatory bowel disease, Crohn's
disease, candida, celiac disease, irritable bowel syndrome, one or
more food allergies, one or more food sensitivities, morning
sickness, menstrual cramps, chronic pain, back pain, facial pain,
fibromyalgia, asthma, migraines, abdominal migraines, cyclic
vomiting syndrome, cluster headaches, chronic headaches, tension
headaches, another type of headaches, seizures, epilepsy,
neurodermatitis, acne, psoriasis, adiposity, hypertonia, heart
disease, hypertension, cardiovascular disease, arteriosclerosis, a
form of cancer, and/or acquired immune deficiency syndrome. The
system and method may also be applied to patients have multiple
illnesses, such a geriatric patients.
[0062] The embodiments of the apparatuses, and related methods, may
be used to collect and analyze information associated with
time-varying phenomena having discrete epochs. The embodiments of
the apparatuses, and related methods, may also be used to identify
one or more association variables for such time-varying phenomena,
thereby allowing remedial action to be taken (if appropriate).
Technical effects for the embodiments of the apparatuses, and
related methods, may include displaying one or more questionnaires,
including a plurality of pre-selected answers, on at least one
display, transmitting and receiving collected information using a
network, determining one or more statistical relationships in at
least one apparatus, identifying one or more association variables
in at least the one apparatus, transmitting and receiving one or
more recommendations and/or one or more reports using the network,
and/or displaying the one or more recommendations and/or the one or
more reports on at least one display.
[0063] The embodiments of the apparatuses, and related methods, may
allow collected data or information to be converted into actionable
information, such as one or more recommendations. In some
embodiments, providing the recommendations to one or more
healthcare providers and/or at least the one individual that has
the disease may help convert this information into knowledge. The
healthcare providers, who practice medicine, may use the knowledge
to aid the one or more individuals that have the disease, including
prescribing one or more diagnostic tests and/or one or more
treatment modalities. In the hands of at least the one individual
that has the disease, the information may motivate behavior
modification that may mitigate or reduce a severity and/or
frequency of one or more symptoms associated with the disease.
[0064] Attention is now directed towards embodiments of
apparatuses, devices, computers, servers, and systems that may be
used to implement the collection of information, the statistical
analysis and/or the providing of recommendations. FIG. 2 is a block
diagram illustrating an embodiment of a system 200 for collecting
data or information, analyzing the information, and/or for
providing recommendations (for example, in one or more reports). A
network 214 couples servers 222 and optional databases 220 (located
in one or more additional computers, servers, and/or network
attached storage devices) to first locations 210 and second
locations 212. The network 214 may include the Internet (also known
as the World Wide Web), an Intranet, a local area network (LAN), a
wide area network (WAN), a metropolitan area network (MAN), and/or
a wireless network (including one or more cellular telephone
networks, Bluetooth networks, Wi-MAX networks, and/or Wi-Fi
networks using IEEE 802.11a, 802.11b, 802.11g and/or 802.11n).
[0065] The first locations 210 may correspond to one or more
individuals or humans beings. In some embodiments, the one or more
individuals may have been diagnosed as having the disease. At least
one of the one or more individuals (henceforth referred to as a
first individual) may interact with at least one of computers 216
and devices 218. The devices 218 may include one or more personal
digital assistants, one or more tablet computers, one or more
cellular telephones, one or more hand-held computers, and/or a
combination of two or more of these items. One or more of the
servers 222 may provide the subset of pre-determined questions one
or more times during the data-collection time interval.
Pre-determined questions may include questions that are determined
prior to the beginning of the data-collection time interval. In
some embodiments, the pre-determined questions may be generated for
at least the first individual prior to the beginning of the
data-collection time interval, for example, in accordance with an
optional initial survey. In exemplary embodiments, the
data-collection time interval may be approximately a fraction of a
day (such as 1, 3, 4 or 6 hours), a day, several days, a week, a
month, 2 months, 3 months, 4 months, 6 months, 9 months, a year,
several years, and/or a combination of one or more of these
items.
[0066] In some embodiments, one or more of the servers 222 may
provide instructions for a web page corresponding to the subset of
pre-determined questions which are rendered in a browser. The
instructions for the web page may include embedded JavaScript
instructions that may be executed by one or more of the computers
216 and/or devices 218. In some embodiments, one or more of the
computers 216 and/or devices 218 may already contain the subset of
pre-determined questions or the set of pre-determined questions.
Configuration instructions, which may be non-executable, from the
one or more servers 222 may select the subset of pre-determined
questions. In other embodiments, at least the first individual may
be asked one or more questions that are not pre-determined, such as
one or more questions that may be dynamically generated in one or
more of the servers 222. Such dynamically generated questions may
be provided approximately in real-time during the data-collection
time interval.
[0067] At least the first individual may provide answers to the
subset of pre-determined questions one or more times during the
data-collection time interval. The answers may be transmitted to
one or more of the servers 222 and/or one or more of the optional
databases 220. In some embodiments, the answers are transmitted at
least in part using email messages and/or SMS messages, or only
using email messages and/or SMS messages. The email messages and/or
SMS messages may be encrypted. One or more of the servers 222, in
conjunction with information stored in one or more of the optional
databases 220, may analyze the answers to determine one or more
statistical relations, the ranking of the variables, and/or to
identify the one or more association variables. One or more of the
servers 222 may revise the subset of pre-determined questions that
are provided and/or provide revised configuration instructions,
which may be non-executable, to at least one of the computers 216
and devices 218 in order to modify the subset of pre-determined
questions for at least the first individual. In some embodiments,
the configuration instructions may be provided at least in part
using email messages and/or SMS messages, or only using email
messages and/or SMS messages. The email messages and/or SMS
messages may be encrypted. The configuration instructions may be
determined in accordance with the answer history for at least a
subset of the one or more individuals, one or more groups of
individuals, and/or default answers to the subset of pre-determined
questions that may be stored in at least one of the optional
databases 220.
[0068] The second locations 212 may correspond to one or more
healthcare providers (such as a physician, nurse, chiropractor,
and/or an associated staff member), one or more parents, one or
more guardians, and/or one or more additional individuals that have
the disease (henceforth referred to as a second individual). In
some embodiments, one or more of the servers 222, in conjunction
with information stored in one or more of the optional databases
220, may provide one or more recommendations in accordance with the
one or more determined association variables to at least the second
individual. In some embodiments, one or more of the servers 222, in
conjunction with information stored in one or more of the optional
databases 220, may provide the one or more recommendations in
accordance with the one or more determined association variables to
at least the first individual at one or more of the first locations
210. The one or more recommendations may be in the form of one or
more reports or documents, including soft or hard copies. In some
embodiments, the recommendations may be provided by transmitting a
data stream including the recommendations and/or transmitting a
data stream including instructions corresponding to the
recommendations (for example, the instructions may correspond to
one or more web-pages) by email, SMS, and/or by regular mail.
[0069] In other embodiments, at least the first individual may be
asked one or more questions that are provided by at least the
second individual. Such questions from at least the second
individual may be dynamically generated and may be provided
approximately in real-time during the data-collection time
interval. Answers to these and/or other dynamically generated
questions (such as those that may be provided by the one or more
servers 222) may be provided to at least the second individual
and/or one or more servers 222 approximately in real-time or after
a time delay. In some embodiment, at least the second individual
may provide feedback and/or instructions to one or more of the
servers 222 that is based on the one or more recommendations. In
some embodiments, the feedback and/or instructions may be used to
revise the configuration instructions. In some embodiments, the
feedback and/or instructions may be used to determine one or more
additional pre-determined questions that are provided to at least
the first individual.
[0070] While the system 200 has been shown with two computers 216
and two devices 218 at the first locations 210, and two computers
216 at the second locations 212, there may be fewer or additional
computers 216 and/or devices 218. In addition, one or more
individuals at the first locations 210 and/or the second locations
212 may share a computer, a device, a set of computers, and/or a
set of devices. Similarly, there may be fewer or more servers 222
and/or optional databases 220. One or more functions of one or more
of the computers 216, devices 218, servers 222, and/or optional
databases 220 may be combined into a single item in the system 200
and/or may be performed at one or more remote locations in the
system 200. One or more positions of one or more items in the
system 200 may be changed. In some embodiments, the functions of
the one or more servers 222 and/or optional databases 220 may be
performed in one or more of the computers 216 and/or one or more of
the devices 218, for example, using one or more applications
programs or modules installed on one or more of the computers 216
or in one or more removable storage media in one or more of the
computers 216. In some embodiments, the one or more applications
programs or modules installed on one or more of the computers 216
or in one or more removable storage media in one or more of the
computers 216 may be dedicated or stand-alone applications that
function without interactions with one of the servers 222 or only
occasionally interact with one or more of the servers 222.
[0071] FIG. 3 is a block diagram illustrating an embodiment of a
server or computer 300, such as one of the computers 216 and/or
servers 222 in FIG. 2. The server or computer 300 includes one or
more processing units (CPUs) 310, at least one network or
communications interface 322 for communicating with other
computers, servers, devices, and/or databases, a memory device 324
with primary and secondary storage, at least one optional user
interface 314, and one or more signal lines 312 for connecting
these components. The one or more processing units (CPUs) 310 may
support parallel processing and/or multi-threaded operation. The
optional user interface 314 may have one or more displays 316,
keyboards 318, pointers 320 (such as a mouse), a touchpad (not
shown), and/or a voice interface 308, including one or more
speakers and/or microphones. The one or more displays 316 may
include a touch screen (which may combine at least one of the
keyboards 318 with at least one of the displays 316). The one or
more signal lines 312 may constitute one or more communication
buses. The network or communications interface 322 may have a
persistent communication connection.
[0072] The memory device 324 may include high speed random access
memory and/or non-volatile memory, including ROM, RAM, EPROM,
EEPROM, FLASH, one or more smart cards, one or more magnetic disc
storage devices, and/or one or more optical storage devices. The
memory device 324 may store an operating system 326, such as LINUX,
UNIX, OS10, or WINDOWS, that includes procedures (or a set of
instructions) for handling various basic system services for
performing hardware dependent tasks. The memory device 324 may also
store procedures (or a set of instructions) in a network
communications module 328. The communication procedures may be used
for communicating with one or more computers 216 (FIG. 2), servers
222 (FIG. 2), optional databases 220 (FIG. 2), and/or devices 218
(FIG. 2). The communication procedures may include those for a
parallel interface, a serial interface, an infrared interface,
Bluetooth, Firewire (IEEE 1394A and/or IEEE 1394B), and/or a USB
interface (for example, USB-1 and/or USB-2 or High-Speed USB). The
communication procedures may include HyperText Transport Protocol
(HTTP) to transport information using the Transmission Control
Protocol/Internet Protocol (TCP/IP), as well as a secure or
encrypted version of HTTP, such as Hypertext Transport Protocol
over Secure Socket Layer (HTTPS), a Layer 2 Tunneling Protocol
(L2TP), or another Internet Protocol Security, such as IPSEC.
[0073] The memory device 324 may also include the following
elements, or a subset or superset of such elements, including a
questionnaire module (or a set of instructions) 330, an
encryption/decryption module (or a set of instructions) 340 (using,
for example, pretty good privacy, symmetric encryption, and/or
asymmetric encryption), a statistical analysis module (or a set of
instructions) 342, a compound variable generator (or a set of
instructions) 346, an optional signal processing module (or a set
of instructions) 350, a report generator (or a set of instructions)
352 for formatting and providing recommendations and related
information to at least one of the first individual and/or the
second individual, pre-determined questions (or a set of
instructions) 354, pre-selected answers (or a set of instructions)
358, pattern of occurrence data 364 corresponding to one or more
events and/or one or more variables, association variable(s) 366,
pre-determined sets of association variables 368, and/or an
optional location module (or a set of instructions) 370 for
determining a location of one or more computers 216 (FIG. 2) and/or
one or more devices 218 (FIG. 2) (for example, using an IP address,
a global positioning system, and/or remote localization capability
associated with a portable device such as a cellular
telephone).
[0074] The questionnaire module 330 may include a client
communication module (or a set of instructions) 332 and/or a
question pattern module (or a set of instructions) 336 for
providing the subset of pre-determined questions to at least the
first individual. The client communication module 332 may include a
web-page generator module (or a set of instructions) 334 that
generates instructions corresponding to one or more web pages,
including HyperText Mark-up Language (HTML), extensible Mark-up
Language (XML), Java, JavaScript, Perl, PHP, and/or NET. The
question pattern module 330 may include a configuration
instructions module (or a set of instructions) 338 for providing
instructions that select the subset of pre-determined questions.
The statistical analysis module 342 may include a ranking module
(or a set of instructions) 344. The compound variable generator 346
may include a threshold module (or a set of instructions) 348 for
determining if one or more entries in the pattern of occurrence
data 364 for at least one variable correspond to a presence or an
absence. The pre-determined questions 354 may include one or more
question modules (or a set of instructions) 356. The pre-selected
answers 358 may include answer history 360 for one or more
individuals and/or one or more groups of individuals, and/or
default answers (or a set of instructions) 362.
[0075] In some embodiments, the server or computer 300 may
communicate with one or more optional physiological monitors 372.
Communication may be via a cable (such as USB), infrared, Firewire
and/or wireless (such as Wi-Fi or Bluetooth). In an alternate
embodiment, at least the first individual may manually enter
physiological data from the one or more optional physiological
monitors 372 using one of the components in the optional user
interface 314. In some embodiments, the physiological data may be
entered using a binary search procedure corresponding to a series
of questions, such as, "Is the physiological data value less than
0.5?," "Is the physiological data value less than 0.25?," "Is the
physiological data value greater than 0.375?," and so on until a
desired precision is obtained. (A similar binary search procedure
may be used to answer one or more pre-determined questions in the
subset of pre-determined questions.) Communication with the one or
more optional physiological monitors 372 may be at discrete times
or it may be continuous. The one or more optional physiological
monitors 372 may include an electroencephalogram monitor (such as a
respective Holter monitor), an electrocardiogram monitor (such as
the respective Holter monitor), an electromyleogram monitor, an
inflammatory response monitor, a respiratory monitor (such as the
Air Watch II) of variables such as peak expiratory flow and/or a
forced expiratory volume in 1 second, a blood glucose monitor, a
blood pressure monitor, a thermometer, a vital sign monitor (such
as those for pulse or respiration rate), a galvanometric response
monitor, and/or a reflex arc monitor.
[0076] Instructions in the modules in the memory device 324 may be
implemented in a high-level procedural language, an object-oriented
programming language, and/or in an assembly or machine language.
The programming language may be complied or interpreted, i.e,
configurable or configured to be executed by the one or more
processing units 310. In addition, the server or computer 300 may
include fewer or additional executable procedures, sub-modules,
tables, and/or other data structures (not shown). In some
embodiments, additional or different modules and data structures
may be used and some of the modules and/or data structures listed
above may not be used. In some embodiments, the functions of two or
more modules may be combined in a single module. In some
embodiments, implementation of functionality of the server or
computer 300 may be implemented more in hardware and less in
software, or less in hardware and more in software, as is known in
the art.
[0077] Although the server or computer 300 is illustrated as having
a number of discrete items, FIG. 3 is intended more as a functional
description of the various features which may be present in the
server or computer 300 rather than as a structural schematic of the
embodiments described herein. In practice, and as recognized by
those of ordinary skill in the art, the functions of the server or
computer 300 may be distributed over a large number of servers or
computers, with various groups of the servers or computers
performing particular subsets of the functions. Items shown
separately in the server or computer 300 may be combined, some
items may be separated and/or additional items may be added. The
apparatuses and methods disclosed may be implemented in hardware
and/or software. In alternate embodiments, some or all of the
functionality of the server or computer 300 may be implemented in
one or more application specific integrated circuits (ASICs) and/or
one or more digital signal processors (DSPs).
[0078] FIG. 4 is a block diagram illustrating an embodiment of a
computer 400, such as one of the computers 216 (FIG. 2). The memory
device 324 may include a browser module (or a set of instructions)
410 for rendering web-page instructions, a transmission/receipt
module (or a set of instructions) 414 for handling information such
the subset of pre-determined questions and corresponding answers,
an optional voice recognition module (or a set of instructions)
416, a display module (or a set of instructions) 418 for displaying
the subset of pre-determined questions and/or the pre-selected
answers to at least the first individual, configuration
instructions 420, and/or a report(s) module (or a set of
instructions) 422 for formatting and presenting recommendations and
related information to at least one of the first individual or the
second individual. The browser module 410 may include instructions
corresponding to one or more web pages 412. The computer 400 may
optionally perform at least a portion of the analysis, such as the
determining at least some of the statistical relationships. The
computer 400 may store pattern of occurrence data 364 corresponding
to one or more events and/or one or more variables. The pattern of
occurrence data 364 may be stored temporarily as the subset of
pre-determined questions are answered over at least a portion of
the data-collection time interval. For example, answers for a
respective day may be transmitted at night. In some embodiments,
the pattern of occurrence data 364 may be communicated to one or
more of the servers 222 (FIG. 2) and/or optional databases 220
(FIG. 2) approximately in real-time, for example, as respective
pre-determined questions are answered. In some embodiments, the
computer 400 may communicate with one or more optional
physiological monitors 372.
[0079] Although the computer 400 is illustrated as having a number
of discrete items, FIG. 4 is intended more as a functional
description of the various features which may be present in the
server or computer 400 rather than as a structural schematic of the
embodiments described herein. In practice, and as recognized by
those of ordinary skill in the art, the functions of the server or
computer 400 may be distributed over a large number of servers or
computers, with various groups of the servers or computers
performing particular subsets of the functions. Items shown
separately in the computer 400 may be combined, some items may be
separated and/or additional items may be added. The apparatuses and
methods disclosed may be implemented in hardware and/or software.
In alternate embodiments, some or all of the functionality of the
server or computer 400 may be implemented in one or more ASICs
and/or one or more DSPs.
[0080] FIG. 5 is a block diagram illustrating an embodiment of a
device 500, such as one of the devices 218 (FIG. 2). The device 500
may include a cellular telephone, a personal digital assistant, a
tablet computer, a Blackberry, a hand-held computer, and/or a
combination of two or more of these items. In some embodiments, the
device 500 may be an implantable medical device that collects and
communicates data for at least the first individual. The device 500
may include one or more data processors, video processors and/or
processors 510, at least one communications interface 512 for
communicating with other computers, servers, devices and/or
databases, a first memory device 516 with primary and/or secondary
storage, a second optional memory device 524 that may be removable,
at least the one user interface 314, a sensor 508, and one or more
signal lines 312 for connecting these components. The one or more
data processors, video processors and/or processors 510 may support
parallel processing and/or multi-threaded operation. The user
interface may have one or more displays 316, keyboards 318,
pointers 320 (such as a mouse or a stylus), a touchpad (not shown),
and/or a voice interface 308 including one or more speakers and/or
microphones. The one or more displays 316 may include a touch
screen (which may combine at least one of the keyboards 318 with at
least one of the displays 316). The one or more signal lines 312
may constitute one or more communication buses. The communications
interface 512 may include a radio transceiver 508 for converting
signals from baseband to one or more carrier bands and/or from one
or more carrier bands to baseband. The communications interface 512
may have a persistent communication connection. The device 500 may
include a power source 514, such as a battery or a rechargeable
battery, for supplying power to one or more of these components.
The sensor 508 may be an imaging element, such as CCD array, for
capturing one or more images (such as pictures).
[0081] The memory device 516 may include high speed random access
memory and/or non-volatile memory, including ROM, RAM, EPROM,
EEPROM, FLASH, one or more smart cards, one or more magnetic disc
storage devices, and/or one or more optical storage devices. The
memory device 516 may store an embedded operating system 518, such
as LINUX, UNIX, OS10, PALM or WINDOWS, or a real-time operating
system (such as VxWorks by Wind River System, Inc.) suitable for
use in industrial or commercial devices. The operating system 518
may includes procedures (or a set of instructions) for handling
various basic system services for performing hardware dependent
tasks, including password and/or biometric security authentication.
The memory device 516 may also store procedures (or a set of
instructions) in a communications module 520.
[0082] The communication procedures in the communications module
520 may be used for communicating with one or more computers 216
(FIG. 2), servers 222 (FIG. 2), optional databases 220 (FIG. 2),
and/or devices 218 (FIG. 2). The communication procedures may
include those for a parallel interface, a serial interface, an
infrared interface, Bluetooth, Firewire (IEEE 1394A and/or IEEE
1394B), and/or a USB interface (for example, USB-1 and/or USB-2 or
High-Speed USB). The communication procedures may include one or
more protocols corresponding to a Global System for Mobile
Telecommunications (GSM), Code Division Multiple Access (CDMA), a
Short Message Service (SMS), an Enhanced Messaging Service (EMS), a
Multi-media Message Service (MMS), a General Packet Radio Service
(GPRS), a Wireless Application Protocol (WAP), instant messaging,
email, TCP/IP, and/or a voice over internet protocol (VoIP). Note
that SMS supports communication of up to 160 characters using, for
example, text messaging. Email may utilize an email address
corresponding to a subscriber's 10-digit telephone number, such as
1234567890@messaging.carrier.com, where `carrier` may be a cellular
telephone provider such as Cingular. EMS includes text formatting,
and supports communication of simple black and white images, as
well as sound tones. MMS supports communication of a wide variety
of media from text to video.
[0083] The memory device 516 may also include the following
elements, or a subset or superset of such elements, including the
optional browser module (or a set of instructions) 410, the
transmission/receipt module (or a set of instructions) 414, the
encryption/decryption module (or a set of instructions) 340, the
optional voice recognition module (or a set of instructions) 416,
an optional voice replication module (or a set of instructions) 522
for asking at least some of the subset of pre-determined questions
using the voice interface 308, the display module (or a set of
instructions) 418, the configuration instructions 420, the optional
statistical analysis module (or a set of instructions) 342, the
optional compound variable generator (or a set of instructions)
346, the optional signal processing module (or a set of
instructions) 350, the optional report(s) module (or a set of
instructions) 422, the optional answer history 360, and/or the
optional pattern of occurrence data 364.
[0084] The optional browser module 410 may include instructions
corresponding to one or more web pages 412. The optional
statistical analysis module 342 may include the optional ranking
module (or a set of instructions) 344. The optional compound
variable module 346 may include the optional threshold module (or a
set of instructions) 348. The device 500 may optionally perform at
least a portion of the analysis, such as determining at least some
of the statistical relationships. The encryption/decryption module
340 may include encryption/decryption that is supported in the GSM
and/or CDMA protocols. In some embodiments, the
encryption/decryption module 340 may include a virtual private
network (VPN) tunneling application.
[0085] The optional pattern of occurrence data 364 may be stored
temporarily as the subset of pre-determined questions are answered
over at least a portion of the data-collection time interval. For
example, answers for a respective day may be transmitted at night.
In some embodiments, the optional pattern of occurrence data 364
may be communicated to one or more of the servers 222 (FIG. 2)
and/or optional databases 220 (FIG. 2) approximately in real-time,
for example, as respective pre-determined questions are
answered.
[0086] In an exemplary embodiment, the configuration instructions
420 and the answers to the subset of pre-determined questions may
be communicating using one or more SMS text messages and/or email
messages. In some embodiments, only SMS text messages and/or email
messages are used. The use of SMS text messaging and/or email
messaging may result in cost savings associated with establishing
accounts and/or with the communication. Receipt of a respective SMS
text message by an end destination, such as one of the servers 222
(FIG. 2), may be confirmed using a handshake message (such as
another SMS message). Upon receipt of such a handshake message, the
device 500 may erase and/or delete information that was transmitted
in the original SMS text message (such as one or more answers to
the subset of pre-determined questions or at least a portion of the
optional pattern of occurrence data 364).
[0087] In some embodiments, at least the first individual may use
the device 500 to collect information that may be subsequently used
to answer one or more of the subset of pre-determined questions.
For example, the sensor 508 may be used to take a picture of a
menu, a table of contents, and/or one or more medicines consumed.
Or an audio file listing items consumed during a meal or snack may
be recorded. The collected information may be processing in the
device 500, or in one or more remote computers and/or one or more
servers, using image processing, text recovery/identification,
and/or speech recognition (using, for example, the optional voice
recognition module 416. In some embodiments, the device 500 may
communicate with one or more optional physiological monitors
372.
[0088] In some embodiments, the device 500 may provide at least the
first individual with at least one reminder (such as a reminder to
take a medicine at a respective time) using one or more messages
transmitted to the device 500 and/or using one or more pre-stored
messages in the device 500 that may be enabled by the configuration
instructions 420. At least the one reminder may be provided using
the voice replication module 522 and the voice interface 308.
[0089] The optional memory device 524 may include one or more FLASH
drives, ROMs, memory sticks, optical storage media (such as
rewritable or ROM CDs and/or DVDs), smart cards, SIMS cards, secure
digital (SD) cards (compatible with devices that use a PALM
embedded operating system), multimedia cards (MMCs), magnetic disc
storage devices (such as disc drives), and/or magnetic media (such
as floppy discs). The optional memory device 524 may also include
the following elements, or a subset or superset of such elements,
including the pre-determined questions (or a set of instructions)
354, the pre-selected answers 358 (or a set of instructions),
and/or the optional account information 526. The pre-determined
questions 354 may include the one or more question modules (or a
set of instructions) 356. The pre-selected answers 358 may include
optional default answers (or a set of instructions) 362. The
optional account information 526 may include at least one carrier
account number (for an Internet service provider, a cellular
telephone provider, and/or a wireless services provider) and/or at
least one telephone number that may enable at least the first
individual to receive the configuration instructions 420 and to
transmit the answers to the subset of pre-determined questions. The
optional account information 526 may allow at least the first
individual to communicate with one or more providers of services
that determine one or more association variables.
[0090] In some embodiments, at least first individual is provided
with the optional memory device 524, which may be installed in the
device 500. One or more additional optional memory devices may also
be provided to at least the first individual at later times during
the data-collection time interval. The one or more additional
optional memory devices may include revised pre-determined
questions 354 and/or revised pre-selected answers 358.
[0091] In some embodiments, the optional memory device 524 is a
SIMS card, an SD card, and/or a memory card and the device 500 is a
cellular telephone. By including the optional account information
526, communication using at least the one carrier account number
and/or at least the one telephone number may avoid the so-called
SIMS card lock that prevents modification of such information in a
cellular telephone that is issued by a cellular telephone provider
to a subscriber. This may allow one or more modules or applications
to be installed and/or executed on the cellular telephone
independently of the cellular telephone provider. Address book
and/or additional telephone numbers (such as a list of frequently
used telephone numbers) on an existing SIMS card, SD card, and/or
memory card for at least the first individual may be copied on to
the optional memory device 524. Alternatively, at least the first
individual may at least temporarily provide the existing SIMS card,
SD card, and/or memory card, which may allow the address book
and/or the additional telephone numbers to be copied on to a new
optional memory device 524 that may be provided to at least the
first individual.
[0092] In some embodiments, the pre-determined questions 354 and/or
the pre-selected answers 358 may be copied on to the optional
memory device 524 or the existing SIMS card, SD card, and/or memory
card in a cellular telephone. Service, such as collecting the
information, may be provided in conjunction with or separately from
one or more cellular telephone service providers. In some
embodiments, revised pre-determined questions 354 and/or revised
pre-selected answers 358 may be transmitted to and stored on the
optional memory device 524 on one or more occasions during the
data-collection time interval.
[0093] In some embodiments, at least the first individual owns or
rents the device 500, thereby reducing a cost associated with
collecting information, as well as a cost and complexity associated
with supporting and maintaining hardware in the field. In some
embodiments, at least the first individual is provided, either
temporarily or permanently, with the device 500.
[0094] The modules and/or some components in the memory device 516
may be arranged in a protocol stack, including a physical layer, a
link layer, a network layer, a transport layer, and/or an
application layer. In an alternate embodiment, the protocol stack
may include the network layer, the transport layer, a security
layer, a session transaction layer, and/or the application layer.
Instructions in the modules in the memory device 516 may be
implemented in a high-level procedural language, an object-oriented
programming language, and/or in an assembly or machine language.
The programming language may be complied or interpreted, i.e,
configurable or configured to be executed by one or more processors
510. In addition, the device 500 may include fewer or additional
executable procedures, sub-modules, tables and other data
structures (not shown). In some embodiments, additional or
different modules and data structures may be used and some of the
modules and/or data structures listed above may not be used. In
some embodiments, the functions of two or more modules may be
combined in a single module. In some embodiments, implementation of
functionality of the device 500 may be implemented more in hardware
and less in software, or less in hardware and more in software, as
is known in the art.
[0095] Although the device 500 is illustrated as having a number of
discrete items, FIG. 5 is intended more as a functional description
of the various features which may be present in the device 500
rather than as a structural schematic of the embodiments described
herein. In practice, and as recognized by those of ordinary skill
in the art, the functions of the device 500 may be distributed over
a large number of servers or computers, with various groups of the
servers or computers performing particular subsets of the
functions. Items shown separately in the device 500 may be
combined, some items may be separated and/or additional items may
be added. One or more items or modules in the memory device 516,
such as the configuration instructions 420, may be stored in the
optional memory device 524 and vice versa. The apparatuses and
methods disclosed may be implemented in hardware and/or software.
In alternate embodiments, some or all of the functionality of the
device 500 may be implemented in one or more ASICs and/or one or
more DSPs.
[0096] Attention is now directed towards embodiments of the
questionnaire and formats for displaying information contained in
embodiments of the questionnaire. As noted previously, the subset
of pre-determined questions may be provided (for example,
displayed) to at least the first individual along with respective
pre-selected answers for each question in at least a plurality of
the pre-determined questions in the subset of pre-determined
questions. In this way, answering a respective pre-determined
question may involve selection if a respective answer to the
respective pre-determined question is different than a respective
pre-selected answer. The pre-selected answers may be selected in
accordance with an answer history, such as the answer history 360
(FIG. 3), and/or default answers, such as the default answers 362
(FIG. 3). FIGS. 6A-6C illustrate embodiments of a questionnaire
including pre-determined questions and pre-selected answers.
[0097] FIG. 6A is a block diagram illustrating an embodiment of a
questionnaire 600, such as a questionnaire module (which may
contain related questions in a category of questions).
Questionnaire modules are discussed further below with reference to
FIGS. 8A and 8B. In the questionnaire 600, several primary
questions 610, including pre-selected answers 616 and alternate
answers 618, are displayed in a window 608. The window may be a
graphical user interface, such as a dialog box or window, and it
may be displayed on a display, such as the display 316 (FIG. 4). A
left edge of at least a plurality of the primary questions 610 may
be aligned with alignment 612-1 such that the primary questions 610
are arranged in a column. A left edge of at least a plurality of
the pre-selected answers 616 may be aligned with alignment 612-3
such that the pre-selected answers 616 are arranged in a column. A
left edge of at least a plurality of the alternate answers 618 may
be aligned with alignment 612-4 such that the alternate answers 618
are arranged in a column. In other embodiments, a right-edge, a
center or another position in the primary questions 610, the
pre-selected answers 616 and/or the alternate answers 618 may be
used for purposes of alignment.
[0098] If the pre-selected answers 616 are correct, at least the
first individual may select a next 624 icon at the bottom of the
window 608 (for example, by positioning a cursor over the accept
624 icon and left clicking on a mouse) to accept the pre-selected
answers 616 and request another window (unless the questionnaire
600 is completed) with additional pre-determined questions and/or
pre-selected answers. Selection of one or more of the alternate
answers 618, such as alternate answer 618-1, may occur if a
corresponding pre-selected answer 616-1 is not the correct answer
for a corresponding primary question, such as primary question
610-1.
[0099] If one or more of the alternate answers 618 are selected,
secondary questions 620 may be displayed and/or enabled (i.e., at
least the first individual may be able to modify the answer to a
secondary question, such as secondary question 620-1). In some
embodiments, when an alternate answer, such as alternate answer
618-1 is selected, a displayed color of one or more of one or more
previously displayed secondary questions 620 may be changed, for
example, from grey to black or from white to black. Note that some
primary questions 610 may not have one or more associated secondary
questions 620 associated with them. The secondary questions 620 may
dependent on or may be conditional on the answers to corresponding
primary questions 610. A left edge of at least a plurality of the
secondary questions 620 may be aligned with alignment 612-2 such
that the secondary questions 620 are arranged in a column. In other
embodiments, a right-edge, a center or another position in the
secondary questions 620 may be used for purposes of alignment. The
alignment 612-2 may be offset 614 from the alignment 612-1.
[0100] In the questionnaire 600, the primary questions 610 may be
categorical or discrete questions, i.e., having answers such as
`yes` or `no`. In some embodiments, the pre-selected answers 616
may include both `yes` and `no` responses. As a consequence, the
pre-selected answers 616 may alternate between `yes` and `no` for
different primary questions 610. In an alternate embodiment, `yes`
answers may be arranged in a first column and `no` answers may be
arranged in a second column, such that a position for the
pre-selected answers 616 and the alternate answers 618 may varying
between the first column and the second column depending on the
primary questions 610. In the questionnaire 600, the secondary
questions 620 may include categorical questions as well as one or
more ordered categorical secondary question 620-2. (A left edge of
the alternate answer 618-4 may be aligned with alignment 612-5. In
other embodiments, a right-edge, a center or another position in
the alternate answer 618-4 may be used for purposes of alignment.)
In an ordered categorical question, there is an ordering between
values (such as answers of `small`, `medium,` or `large`) but a
scale or metric value may vary (a difference between `medium` and
`small` may be different than a difference between `large` and
`medium`). In some embodiments, an ordered categorical question may
have a pre-selected answer, such as pre-selected answer 616-3, that
is in a different column than other pre-selected answers 616. This
may be useful when the ordered categories are time intervals, such
as morning, afternoon, etc., and the pre-selected answer is not the
left-most ordered category. Rather than rearranging the ordered
categories, the pre-selected answer 616-3 may be in a different
column.
[0101] In some embodiments, the primary questions 610 and the
secondary questions 620 may include categorical, ordered
categorical and/or quantitative questions. Quantitative questions
have answers that are continuous variables. Answers to quantitative
questions may be partition, for example using one or more
thresholds or threshold values, to generate categorical or ordered
categorical answers. In some embodiments, answers to one or more
quantitative questions may be band limited prior to partitioning to
reduce or eliminate aliasing. Categorical or ordered categorical
answers may be converted into continuous answers using
interpolation (such as minimum bandwidth interpolation), subject to
the limitations associated with the Nyquist sampling criterion.
[0102] In the questionnaire 600, the window 608 may include one or
more help icons 632, a home icon 622 to return to a master page in
the questionnaire 600, a jump icon 626 to save answers and skip to
another window, an exit icon 628 to save answers and exit the
questionnaire 600. While the questionnaire 600 includes three
primary questions 610 and three secondary questions 620, there may
be fewer or more of either type of question. In some embodiments, a
respective question may have one or more answers.
[0103] FIG. 6B is a block diagram illustrating an embodiment of a
questionnaire 640. Selection of a respective alternate answer, such
as alternate answer 618-6 (FIG. 6A), to one of the primary
questions 610 (FIG. 6A) or secondary questions 620 (FIG. 6A) may
lead to window 652 being displayed. The window 652 may include one
or more help icons 664, and one or more items 654 with one or more
quantities 658 and units 660 (henceforth collectively referred to
as entries) during corresponding time intervals 656. At least the
first individual may accept the entries using an accept icon 662
after making modifications (if any). Modifications may be made to
one or more entries by positioning a cursor over an entry and
manually typing one or more new values and/or by left clicking on
the mouse with the cursor over the entry and selecting a new value
from a list box (a static object in the window 652) that appears
when the mouse is positioned over it and/or a content-dependent
list or menu (a dynamic object) that may appear as a separate
window when the mouse is positioned over it. A list box and/or a
content-dependent list or menu may include related objects and/or
items, such as those corresponding to a category of items. In some
embodiments, the entries in the window 652 may blink to indicate
that at least the first individual may modify one or more of them.
In an exemplary embodiment, the items 654 may include
pharmacological agents, prescription drugs, vitamins, herbs,
supplements and/or recreational or illicit drugs (henceforth
referred to as pharmacological agents). The quantities 658 and
units 660 may correspond to dosages. The time intervals 656 may be
a fraction of a day, such as approximately 1, 2, 3, 4, 6, 8, and/or
12 hours. Thus, 50 mg of a drug taken in the morning (such as
between 6 AM and 11.59 AM), may correspond to a quantity 658-1 of
`50` and a unit 660-1 of `mg`. The entries in the window 652 may be
pre-selected based on the answer history, default answers, and/or
answers to one or more questions in the optional initial survey,
which may include the usage of pharmacological agents (times and
dosages) by at least the first individual. The optional initial
survey may be conducted prior to or at the beginning or the
data-collection time interval during which the subset of
pre-determined questions corresponding to the questionnaire are
asked.
[0104] FIG. 6C is a block diagram illustrating an embodiment of a
questionnaire 670. A window 682 may include a table 688 including
one or more items 684 and/or a list 692 including one or more
categories 690. Each of the items 684 may have ordered categorical
answers such as quantities 686. For example, quantity 686-1 may be
`less than usual`, quantity 686-2 may be `usual`, quantity 686-3
may be `more than usual`. One or more respective quantities 686,
such as the quantity 686-1, for one or more respective items 684,
such as the item 684-1, may be pre-selected. Categories 690 may be
list boxes, and/or content-dependent lists or menus. The categories
690 may correspond to food or beverage categories, such as
vegetables, fruits, meats, etc.
[0105] In an exemplary embodiment, the window 682 may be used to
collect information corresponding to one or more meals or snacks,
such as foods eaten or beverages consumed. In some embodiments,
snacks eaten between meals may be included in the nearest previous
meal. For example, a snack after dinner and before breakfast may be
included with the entries for dinner. The items 684 may be included
in accordance with answers to one or more pre-determined questions
in the subset of pre-determined questions during a current
questionnaire session (for example, in another questionnaire
module) and/or may be previously consumed foods (which may be
stored in an answer history, such as the answer history 360 in FIG.
3, corresponding to one or more previous answer sessions, i.e., on
one or more earlier occasions). The one or more pre-selected
quantities may be in accordance with the answer history. The
previously consumed foods may be the most common foods (for
example, a top 10 list) consumed by at least the first individual.
At least one of the categories 690 may include additional consumed
foods and/or previously consumed foods for at least the first
individual that are not displayed in the table 688. The items 684
may include food brand and/or food category (such as Italian)
information. In some embodiments, food brand and/or food category
may be displayed using icons (not shown) situated between the items
684 and the quantities 686.
[0106] One or more items 684 may be selected by clicking on one or
more radial buttons 680 (for example, positioning the mouse over a
respective item and left clicking the mouse). A displayed color of
one or more selected items may be changed, for example, from grey
to black. In some embodiments, the window 682 may be refreshed such
that selected items are displayed starting at the top of the table
688 and items that are currently not selected are displayed below
the selected items, i.e., towards the bottom of the table 688.
Additional items for inclusion in the table 688 may be selected
from one or more categories 690 and/or may be manually entered
using one or more optional manual entry boxes 694.
[0107] Selecting a category, such as category 690-1, may lead to a
content-dependent list or menu being displayed in a separate dialog
box or window. Entries selected from one or more categories 690 may
be displayed in the table 688 as additional items with pre-selected
quantities and/or pre-selected radial buttons. The window 682 may
be refreshed and/or re-ordered when one or more of such entries are
displayed. At least the first individual may modify, as needed, one
or more pre-selected quantities for one or more of such entries
displayed in the table 688 (for example, if one or more of the
pre-selected quantities did not correspond to one or more actual
quantities consumed by at least the first individual). In some
embodiments, entries in the window 670 that may be modified, such
as the one or more pre-selected quantities and/or the optional
manual entry box 694, may blink to indicate that at least the first
individual may modify one or more of them. Selecting an addition
698 icon may display a window that allows at least the first
individual to add one or more entries to one or more categories
690. Alternative, the separate dialog box or window for a
respective content-dependent list that has been selected may
include a manual entry option so at least the first individual may
add one or more entries to the respective content-dependent list.
The optional manual entry boxes, such as the optional manual entry
box 694, in the table 688 may be used to enter one or more new
items, food brands, and/or food categories. Corresponding
quantities may be entered using the quantities 686. While the
questionnaire 670 shows one optional manual entry box 694, in some
embodiments there may be additional manual entry boxes in one or
more additional rows. Each row may be used to enter at least one
new item.
[0108] In embodiments where windows in the questionnaire 670 are
provided in one or more web pages, JavaScript instructions included
with the one or more web pages may allow the table 688 to be
updated without blinking the displayed window 682, i.e., without
transmitting revised web page instructions from a remote server or
computer, such as the server or computer 300 (FIG. 3). In the
questionnaire 670, the window 682 may include one or more help
icons 696, the home icon 622, the next icon 624, the jump icon 626
and/or the exit icon 628. In some embodiments, the window 682 may
include additional or fewer items 684 and/or categories 690.
[0109] A better understanding of the questionnaire and the
determining of one or more association variables (described further
below with reference to FIGS. 9-14) may be provided by considering
application to a class of problems, such as those associated with
one or more diseases. Migraines are used as an illustrative
example. In this example, at least the first individual may be a
migraine patient. In some embodiments, migraines may include
probable migraine, also referred to as migrainous, in which
patients exhibit migraines minus one migraine symptom (which are
discussed below).
[0110] Migraine is a neurovascular disorder characterized by a
family of symptoms that often include severe, recurring headache
usually on one-side of the head. Migraine attacks are debilitating
and have a duration that may last from several hours to days.
During attacks, many patients also exhibit sensitivity to
environmental stimuli, such as light and sound, and/or experience
nausea or vomiting. Some characteristics of migraines, with and
without aura, are summarized in Tables I and II. Migraines
typically follow a cycle, including an initial or prodrome phase
during which premonitory symptoms (discussed further below with
reference to FIG. 8A) may be present, an aura phase (for patients
that have migraine with aura) during which visual disturbances may
be present, a resolution or recovery phase, and a normal (i.e.,
non-migraine) phase. TABLE-US-00001 TABLE I Some characteristics of
migraine without aura. A. Headache attacks lasting 4-72 hours
(untreated or unsuccessfully treated). B. Headache has at least two
of the following characteristics: 1. Unilateral location; 2.
Moderate or severe pain intensity; 3. Pulsating quality; 4.
Aggravated by or causing avoidance of routine physical activity
(for example, walking or climbing stairs). C. During headache at
least one of the following: 1. Nausea and/or vomiting; 2. Light
sensitivity (photophobia) and sound sensitivity (phonophobia).
[0111] TABLE-US-00002 TABLE II Some characteristics of migraine
with aura. A. Aura consisting of at least one of the following, but
no motor weakness: 1. Fully reversible visual symptoms including
positive features (for example, flickering lights, spots or lines)
and/or negative features (such as, loss of vision); 2. Fully
reversible sensory symptoms including positive features (such as,
pins and needles) and/or negative features (such as, numbness); 3.
Fully reversible dysphasic speech disturbance. B. At least two of
the following: 1. Homonymous visual symptoms and/or unilateral
sensory symptoms; 2. At least one aura symptom develops gradually
over .gtoreq.5 minutes and/or different aura symptoms occur in
succession over .gtoreq.5 minutes; 3. Each symptom lasts .gtoreq.5
and .ltoreq.60 minutes. C. Headache fulfilling criteria B-D for
migraine without aura (Table I) begins during the aura or follows
aura within 60 minutes.
[0112] The medical approach to managing migraine headaches is
typically three-pronged, including acute therapy, preventive
therapy, and identification and avoidance of migraine triggers.
Acute therapy includes administering acute or prophylactic
pharmacological agents, such as painkillers or analgesics, (for
example, aspirin, acetaminophen or naproxen), ergotamine,
dihydroergotamine, and/or a new class of medications known as
"triptans" (selective serotonin 5-hydroxytryptamine or 5-HT
receptor agonists, such as imitrex and maxalt), which are
migraine-specific medications that may treat the entire migraine
complex, relieving the head pain, nausea, vomiting, and associated
light and sound sensitivity, typically within 1-2 hours. Most
patients with migraine are prescribed one or more forms of acute
therapy.
[0113] Preventive therapy includes pharmacological agents or
medications taken on a daily basis to reduce migraine headache
frequency (a number of headaches during a time period) and severity
(for example, a rating of headache pain by a patient). These
pharmacological agents may be taken whether a migraine headache is
present or not. Prevention strategies are typically employed for
patients who suffer from one or more migraine headaches per week.
Only a minority of patients require this form of therapy.
[0114] Identification and avoidance of migraine triggers is
typically a mainstay in the treatment of patients suffering from
migraine. If patients successfully avoid their migraine triggers,
migraine headache frequency and severity may be improved. (Note
that some migraine triggers, such as certain hormones, may be
intrinsic or internal to the patient. As such, the patient may
still have spontaneous migraine attacks even if he or she
successfully avoids his or her dominant migraine triggers.)
Identifying migraine triggers, however, remains challenging and is
often a source of frustration for patients and healthcare
providers. This is partly an outgrowth of the apparent complexity
of migraine triggers. A myriad of probable or putative migraine
triggers are thought to exist. It has been hypothesized that the
migraine triggers may vary significantly from one patient to
another, may vary within a respective patient (as discussed below
with reference to FIG. 7, the respective patient's sensitivity
threshold for a respective trigger may vary as a function of time),
may depend on a quantity of exposure, and/or may depend on exposure
to two or more triggers in close temporal proximity.
[0115] In addition, current approaches for screening for migraine
triggers may pose challenges. Typically, patients are given paper
diaries and are asked to list what they think may have triggered an
attack on a respective day. This approach may rely on the patients'
recall of events, as diaries are often filled in days after a
migraine attack, and may therefore miss an exposure to migraine
triggers. Patients may also assign a cause when one may not exist,
or patients may assign blame to an incorrect variable(s). The
apparent complexity of migraine triggers may compound these
difficulties.
[0116] FIG. 7 is a block diagram illustrating an embodiment 700 of
migraine triggers and sensitivity thresholds. A plurality of
variables 712, corresponding to migraine triggers, each having a
length corresponding to an amount of exposure 714 during a time
interval are illustrated. Sensitivity thresholds 710 illustrate
several effective sensitivities for at least the first individual.
At any given time, one or more of the sensitivity thresholds 710
may be operative for one or more of the variables 712. The
sensitivity thresholds 710 may vary as a function of time. Such
variation may occur slowly, for example, over a period of months or
even years. Variables 712 that exceed one of the sensitivity
thresholds 710 corresponding to a current sensitivity for at least
the first individual, such as variable B 712-2 and sensitivity
threshold 710-2, may trigger a migraine attack. Alternatively,
combinations of variables 712, such as variable C 712-3 and
variable F 712-6, may exceed a sensitivity threshold 710-3 and
trigger a migraine. The combinations may be cumulative, may
correspond to variables 712 that occur in close temporal proximity,
may correspond to respective temporal sequences of variables 712,
and/or may correspond to respective ordered temporal sequences of
variables 712 during the data-collection time interval. While
embodiment 700 illustrates 7 variables 712, in some embodiments
there may be fewer or more variables 712.
[0117] Other intricacies associated with migraines are so-called
rebound and recurrence headaches. While analgesics are designed to
relieve pain, if such pharmacological agents (both prescription and
nonprescription) are overused (repetitive and chronic use), they
can actually cause headaches. This is known as analgesic rebound
headache (ARH) or "rebound headache." Headache sufferers taking
analgesic medications every day, or even as infrequently as two
times a week, may find that they must take ever-increasing dosages
to achieve relief. With continued overuse the medication becomes
less and less effective, with pain-free periods between headaches
becoming shorter and shorter. The result can be a self-sustaining
cycle of increasing pain and medication.
[0118] Recurrences headaches are associated with headaches
returning after a pain-free period following treatment with one or
more medicines. In essence, the migraine attack "outlasts" the
treatment, so the headache returns when the medication wears off.
Recurrence is commonly seen following treatment with a triptan. For
example, a headache resolves within one to two hours after taking a
triptan, only to return full blown (i.e., with full severity)
within 24 hours. In some embodiments, a recurrence headache may be
defined as any headache occurring after a headache-free state at 2
hours and within 12 hours after intake of an acute pharmacological
agent. In some embodiments, a recurrence headache may be defined as
any headache occurring after a headache-free state at 2 hours and
within 24 hours after intake of an acute pharmacological agent. A
recurrence headache may have different characteristics of
intensity, severity and/or associated features than an original
headache episode during a migraine attack. In some cases, a
recurrence headache may be of migraine or tension-type. (Some
characteristics of tension headaches are summarized in Table III.)
TABLE-US-00003 TABLE III Some characteristics of tension headaches.
A. At least 2 of the following 4 headache features: 1. Bilateral
location; 2. Pressing/tightening quality; 3. Mild or moderate
intensity; 4. Not aggravated by routine physical activity. B. Both
of the following: 1. No nausea or vomiting 2. Not more than one of
light or sound sensitivity. C. Duration lasting from 30 minutes to
7 days.
[0119] In the context of the disclosed embodiments, the one or more
events may be one or more migraines, and the one or more temporal
onsets corresponding to the one or more events may be a respective
onset time and/or a respective onset time interval for one or more
migraines. Onset times for migraines may be determined in
accordance with one or more premonitory symptoms (discussed further
below with reference to FIG. 8A) that may be experienced by at
least the first individual during the prodrome phase of a migraine
attack, one or more migraine symptoms during the aura phase of a
migraine attack, one or more migraine symptoms during the headache
phase of a migraine attack, and/or an onset of head pain as
indicated by at least the first individual.
[0120] In some embodiments, the one or more physiological monitors
372 (FIG. 3) may, at least in part, determine one or more onset
times for migraines. Since migraines impact the hypothalamus, with
consequences for the endocrine system, the limbic system and the
autonomic nervous system, a variety of physiological changes may be
observable in one or more migraine patients. These physiological
changes may include changes in a circadian rhythm, changes in one
or more vital signs (such as pulse, respiration, systolic blood
pressure, and/or diastolic blood pressure), hormonal changes,
emotional changes, changes in a pulse pressure (defined as a
difference of the systolic blood pressure and the diastolic blood
pressure), changes in skin electrical or thermal conductivity (such
as perspiration), and/or changes in at least one reflex arc. The
physiological changes may be bilateral or unilateral. In an
exemplary embodiment, the pulse pressure may increase or decrease
by 1%, 3%, 5% or more than 10% during the prodrome phase. In some
embodiments, the one or more physiological monitors 372 (FIG. 3)
may determine a presence of (sub-) cutaneous allodynia or `skin
pain` (such as a sensitive or painful scalp), a condition
associated with central sensitization, which is indicative of a
deeply entrench migraine attack. In some embodiments, the one or
more physiological monitors 372 (FIG. 3) may provide a metric of
chronic disease regulation, for example, a frequency and/or a
severity of migraines.
[0121] The pre-determined questions in the questionnaire, such as
the questionnaire 600 (FIG. 6A), may correspond to patterns of
occurrence (including presence and absence information) of the set
of variables that are potential migraine triggers. The one or more
association variables may correspond to one or more migraine
triggers, and/or one or more probable or putative migraine
triggers. The one or more association variables may be
patient-specific, may occur in one or more groups of migraine
patients, and/or may occur in at least a plurality of migraine
patients. The one or more association variables may at least in
part induce a migraine in at least the first individual if at least
the first individual is exposed to one or more of the association
variables. In some embodiments, the one or more association
variables may be the dominant migraine triggers, such as those
migraine triggers associated with 10%, 25%, 33%, 50%, or more of
the migraine attacks, for at least the first individual.
[0122] Variables that may be migraine triggers may include weather
changes, allergens, compounds containing phenols (also referred to
as phenolic compounds), pollution, hormonal fluctuations (such as
during the menstrual cycle, pregnancy, post partum, and/or
menopause), trauma, illness, hypoglycemia, sensory stimuli (such as
lights, sounds, and/or smells), physical exertion, sexual activity,
motion, travel, sleep patterns (when and/or how much sleep),
intense emotion, withdrawal of intense emotion, stress, withdrawal
of stress, certain pharmacological agents (such as MAO inhibitors,
oral contraceptives, estrogen replacement therapy, recreational
drugs, and/or tobacco products), dietary patterns (when food is
consumed), and/or diet (what and/or how much is consumed). Dietary
migraine triggers may include alcohol (for example, wine), sugar
substitutes (such as Aspartame), caffeine (including caffeine
withdrawal), food additives (such as monosodium glutamate or MSG),
one or more fruits, one or more vegetables, one or more spices, one
or more nuts, fermented food (such as vinegar), foods containing
amounts of certain amino acids (such as tyramine) that exceed one
or more quantity thresholds, foods containing amounts of nitrates
that exceed a first quantity threshold, foods containing amounts of
sulfites that exceed a second quantity threshold, and/or foods
containing amounts of tannins that exceed a third quantity
threshold. For example, dietary migraine triggers may include blue
cheese, oranges, carrots, vinegar and caffeine.
[0123] Attention is now directed towards application of the
embodiments of the questionnaire for collecting information
associated with migraines, such as variables corresponding to
potential or putative migraine triggers. It should be understood,
however, that the description applies to numerous applications and
embodiments, including non-medical applications.
[0124] Prior to or at the beginning of the data-collection time
interval, at least the first individual may answer one or more
questions in the optional initial survey. In some embodiments, the
questions may be based on at least the first individual's medical
history. The optional initial survey may confirm that at least the
first individual meets any applicable entry criteria, determine one
or more questionnaire modules (discussed further below with
reference to FIG. 8A) that may be relevant for at least the first
individual, and collect initial information, such any
pharmacological agents that at least the first individual takes on
a regular basis (for example, daily). In the case of migraines,
entry criteria may include determining that the disease in a
respective patient, such as at least the first individual, is
sufficiently well controlled that migraine attacks are not
occurring too often (such as every day) or too infrequently (such
as once a year) to preclude determination of one or more migraine
triggers. For migraines, pharmacological agents may include one or
more acute therapies and/or one or more preventive therapies. The
pharmacological agents may include other medicines (prescription
and/or non-prescription), vitamins, herbs, supplements, and/or
recreational drugs that at least the first individual takes on a
regular basis. The initial information may include quantities
and/or times when one or more of the pharmacological agents are
used.
[0125] As noted above, pre-determined-questions in the
questionnaire may be grouped into questionnaire modules. FIG. 8A is
a block diagram illustrating an embodiment of a questionnaire data
structure 800 including multiple pre-determined questions, such as
the pre-determined questions 354 (FIG. 3), arranged in multiple
questionnaire modules, such as the questionnaire modules 356 (FIG.
3). The questionnaire data structure 800 may include sleep pattern
questions 810 (including questions related to sleep apnea and/or
insomnia), dietary questions 812 (such as dietary patterns and
diet), behavioral questions 814 (such as hormonal fluctuations,
physical exertion, sexual activity, motion, travel, exposure to
intense emotion, withdrawal of intense emotion, exposure to stress,
withdrawal of stress, and/or a use of tobacco products),
environmental questions 816 (such as exposure to sensory stimuli,
exposure to compounds containing phenols, and/or exposure to
weather conditions such as strong wind), overall health questions
818 (such as pregnancy, a presence of trauma, illness, depression,
and/or hypoglycemia), premonitory questions 820, migraine questions
822, medicine usage questions 824 (such as preventive therapies,
vitamins, herbs, oral contraceptives, estrogen replacement therapy,
recreational drugs, and/or pharmacological agents, including
analgesics, other than migraine-specific drugs such as triptans),
and/or derived variable(s) questions 826.
[0126] The premonitory questions 820 include symptoms that may be
experienced and/or exhibited by at least the first individual
during the prodrome phase of a migraine attack. Premonitory
symptoms may include excitatory symptoms, inhibitory symptoms
and/or localized pain (for example, in the head, neck and/or
shoulders). Excitatory symptoms may include cravings (such as
hunger and/or thirst), increased activity, sweating, a sense of
well being, emotional changes (such as irritability), increased
urination or bowel movements, and/or increased sensitivity to
sensory stimuli. Inhibitory symptoms may include confusion,
difficulty concentrating, depression, dizziness, fatigue,
constricted circulation, yawning, and/or a lack of appetite.
[0127] The migraine questions 822 may include migraine occurrence
information, migraine information (such as pain location, severity,
quality or description, patterns, and/or temporal variation), use
of medicines (including pharmacological agents such as one or more
acute therapies), use of non-pharmacological treatments, a presence
of visual disturbances, symptoms of (sub-) cutaneous allodynia,
and/or other migraines symptoms (such as nausea and/or vomiting).
The migraine occurrence information may include one or more
temporal onsets or onset times.
[0128] In some embodiments, at least the first individual may be
asked the derived variable(s) questions 826. One or more answers to
the derived variable(s) questions 826 may be determined in
accordance with one or more answers to one or more pre-determined
questions in one of the other questionnaire modules. For example,
exposure to a food containing tyramine may be determined based on
one or more answers to one or more pre-determined questions in the
dietary questions module 812. One or more answers to the derived
variable(s) questions 826 may be determined in accordance with a
mapping operation performed on one or more answers to one or more
pre-determined questions in the dietary questions module 812. For
example, one or more foods consumed (such as mayonnaise) may be
mapped to basic constituents (egg, vinegar, and/or mustard) and/or
elemental constituents (minerals, fats, carbohydrates, and
proteins). The mapping operation may be performed using tables of
related information, such as one or more recipes and/or elemental
constituent information. Elemental constituent information for some
foods may be obtained in the National Nutrient Database on the
United States Department of Agriculture's website at
www.nal.usda.gov/fnic/foodcomp/Data. One or more answers to the
derived variable(s) questions 826 may be determined in accordance
with other public information, such as weather (conditions and/or
changes), altitude, allergen, and/or pollution information. For
example, pollution information may be obtained from the United
States Environmental Protection Agency's website at
www.epa.gov/air/data. In some embodiments, one or more answers to
the derived variable(s) questions 826 may be determined in
accordance with at least the first individual's location(s), which
may determined using the optional location module 370 (FIG. 3),
during the data-collection time interval.
[0129] The pre-determined questions in one or more of the
questionnaire modules may correspond to deviations from normal or
usual behavior for at least the first individual. For example,
deviations from normal sleep patterns for at least the first
individual, deviations from normal behavior while at least the
first individual is awake, and/or deviations from normal dietary
behavior for at least the first individual.
[0130] In some embodiments, a respective questionnaire module, such
as the dietary questions 812, may include primary questions, such
as the primary questions 610 (FIG. 6A), and secondary questions,
such as the secondary questions 620 (FIG. 6B). For example, the
dietary questions 812 may include are primary questions such as
pre-determined questions 828 ("Did you miss a meal today?"), 832
("Did you have your snack at the usual time?") and 836 ("Did you
eat at a restaurant today?"). Pre-determined questions 830-1 (Did
you miss breakfast today?"), pre-determined questions 830-2 ("Did
you miss lunch today?"), pre-determined questions 830-3 ("Did you
miss dinner today?"), pre-determined questions 834-1 ("Was the
snack early or late?") and pre-determined questions 834-2 ("How
[Early or Late] was the snack?") may be secondary questions. Note
that pre-determined (secondary) question 834-2 may depend on the
answer to pre-determined (secondary) question 834-1.
[0131] At least some of the dietary questions 812 may be displayed
using a format such as that illustrated in FIGS. 6A and/or 6C.
Other questions in one or more other questionnaire modules may be
displayed using a format such as that illustrated in FIGS. 6B. For
example, medicine usage questions 824 and/or the use of medicines
pre-determined questions in the migraine questions 822 may be
displayed using the format in FIG. 6B. Pre-selected answers 616
(FIG. 6A) for some of the pre-determined questions may correspond
to a usual or a normal behavior for at least the first individual
in accordance with at least the first individual's answer history
360 (FIG. 3), the answer history 360 (FIG. 3) for one or more
groups (such as men, women, an age group, a demographic group,
groups of migraine patients, and/or groups of migraine patients
having one or more migraine triggers in common), one or more
answers to the optional initial survey, and/or one or more default
answers 362 (FIG. 3).
[0132] Answers, be they pre-selected or not, to the pre-determined
questions in the dietary questions 812, as well as in one or more
other questionnaire modules, may be categorical, ordered
categorical, and/or quantitative. For example, the answer to
pre-determined question 828 may be `yes` or `no`. The answer to
pre-determined (secondary) question 834-2 may be quantitative (a
time in hours, minutes and/or seconds) and/or ordered categorical
(between 0-1 hours, between 1-2 hours, etc.). Ordered categorical
answers to some of the primary or secondary questions may include
time intervals, such as the time intervals 656 (FIG. 6B), that
correspond to a fraction of a day. In an exemplary embodiment, a
presence or absence of a respective variable may be determined in
accordance with a selection of a `yes` answer to a primary question
and a selection of one or more time intervals that correspond to a
fraction of a day in answer to a related secondary question. The
time intervals may include night, morning, afternoon and evening,
where night is between 12 am and 5.59 am, morning is between 6 am
and 11.59 am, afternoon is between 12 pm and 5.59 pm and evening is
between 6 pm and 11.59 pm.
[0133] The questionnaire data structure 800 may include fewer or
additional questionnaire modules. One or more of the questionnaire
modules may include one or more questions corresponding to feedback
from at least the first individual and/or suggestions for
additional variables to be tracked (information to be collected)
and/or analyzed. Such feedback may allow a knowledge base to grow
and improve as the approach is scaled to more individuals. Two or
more questionnaire modules may be combined. Some pre-determined
questions may be included in more than one questionnaire modules.
One or more questionnaire modules may include fewer or more
pre-determined questions. In some embodiments, one or more
pre-determined questions may be moved from one questionnaire module
to another.
[0134] As noted previously, the subset of pre-determined questions
may be varied during the data-collection time interval, i.e., the
questionnaire may be used dynamically. The varying may be in
accordance with the configuration instructions 420 (FIG. 4), with
providing one or more pre-determined questions 354 in FIGS. 3 and 4
(for example, in a data stream that is transmitted and stored in
the memory device 324 in FIG. 3), with providing instructions
corresponding to one or more pre-determined questions (such as in
instructions corresponding to one or more web pages 412 in FIG. 4),
and/or with providing the optional memory device 524 in FIG. 5
containing one or more pre-determined questions 354.
[0135] In some embodiments, an initial phase of the data-collection
time interval may, at least in part, correspond to a training
phase, for at least the first individual (i.e., how to answer the
pre-determined questions), for one or more of the apparatuses,
and/or for one or more algorithms implementing the questionnaire
(for example, how best to determine the one or more temporal onsets
for at least the first individual). During the training phase, the
subset of pre-determined may initially include one or more
pre-determined questions selected from the premonitory questions
820, the migraine questions 822 and/or the medicine usage questions
824.
[0136] The questionnaire, and the related statistical analysis
(described below with reference to FIGS. 9-14), may be applied
iteratively. For example, pre-determined questions in one or more
of the questionnaire modules may be tree-based or hierarchical,
ranging from general or broad in scope to narrow or specific in
scope. General pre-determined questions may be asked one or more
times during the data-collection time interval. Based on one or
more answers to these general pre-determined questions, additional
narrow pre-determined questions may be asked one or more times. In
some embodiments, the subset of pre-determined questions may be
asked, one or more association variables (for example, migraine
triggers) may be identified and at least the first individual may
exclude one or more of the identified association variables (for
example, by modifying behavior, changing diet, etc.). This process
of asking, identifying and excluding may be repeated one or more
times until diminishing returns (for example, it may become
difficult to readily and/or reliably identify one or more
additional association variables).
[0137] FIG. 8B is a block diagram illustrating an embodiment of a
questionnaire 850 that is dynamic and hierarchical. One or more
pre-determined questions in question modules are included in the
subset of pre-determined questions as a function of time 852.
General sleep pattern questions 854 may be included. Specific sleep
pattern questions 856 may be included on two occasions. General
behavioral questions and specific migraine questions 858 may be
included. Specific migraine questions 860 may be included. The
questionnaire 850 is meant to be illustrative of a dynamic
questionnaire and is not indicative of a specific implementation.
Thus, there may additional or fewer portions of question modules,
additional or fewer question modules, an order or two or more of
the question modules may be changed, at least a portion of two or
more the question modules may be combined, and/or at least a
portion of one or more additional question modules may be included
at any instance in time.
[0138] In order to reduce or eliminate inaccuracies associated with
memory or recall errors, in some embodiments at least the first
individual may not be able to answer or modify answers in one or
more subsets of pre-determined questions, such as those in the
questionnaire 850, that were asked at previous instances in time,
for example, on one or more previous days.
[0139] Attention is now directed towards embodiments of the
statistical analysis, including the determination of one or more
statistical relationships between one or more temporal onsets and
one or more variables and/or one or more compound variables, and
the identification of one or more association variables. The
statistical analysis may include classification and/or regression
(such as determining a model of the temporal onsets including one
or more variables and/or one or more compound variables with
corresponding weights). FIG. 9A is a block diagram illustrating an
embodiment 900 of determining a compound variable 920 associated
with events having different temporal onsets 910. In some
embodiments, the events may be migraine attacks and the temporal
onsets 910 may be onset times for migraine attacks. Temporal onsets
910 are shown as a function of time 908. The temporal onsets 910
may include one or more onset times and/or one or more onsets
during one or more time windows or time intervals. There is a time
delay 922 between temporal onset 910-1 and temporal onset 910-2. An
inverse of the time delay 922 may correspond to a frequency of the
events. Patterns of occurrence of variable A 914 and variable D
916, including instances or entries corresponding to presence
information (illustrated by arrows) and corresponding to absence
information (illustrated by absences of arrows), as function of
time 908 are illustrated on separate but identical axes for
clarity.
[0140] The compound variable 920 may correspond to at least a
pattern of occurrence of variable A 914 during a first time
interval 912 preceding the temporal onsets 910 and a pattern of
occurrence of variable D 916 during a second time interval 918
preceding the temporal onsets 910. Note that in embodiment 900, the
first time interval 912 may be offset 924 from the temporal onsets
910. In some embodiments, the first time interval 912, the second
time interval 918, and/or additional time intervals corresponding
to additional variables may be offset from the temporal onsets 910.
In some embodiments, a pattern of occurrence of at least one
variable may be in accordance with one or more time intervals
having a width that corresponds to a precision of a time
measurement, i.e., each of the one or more time stamps corresponds
to a respective time.
[0141] In some embodiments, the first time interval 912, the second
time interval 918, and/or other time intervals may have the same
duration and/or offsets 924. In some embodiments, the first time
interval 912, the second time interval 918, and/or other time
intervals may have a different duration and/or offsets 924. In some
embodiments, one or more of the time intervals may be adjustable.
In exemplary embodiments, the time intervals may have a duration of
a fraction of a day (such as 1, 2, 3, 4, 6, 12, and/or 18 hours),
one day, two days, three days, more days, and/or combinations of
these items. In some embodiments, offsets, such as offset 924, may
be between 0 and up to 3, 5, and/or 10 days or more. In exemplary
embodiments, the offset 924 may be a fraction of a day (such as 1,
2, 3, 4, 6, 12, and/or 18 hours), one day, two days, three days,
more days, and/or combinations of these items.
[0142] A respective instance or entry for the compound variable
920, such as compound variable 920-1, may correspond to a presence
if variable A is present during the first time interval 912-1 (a
presence entry in the pattern of occurrence of variable A 914) and
variable D is present during the second time interval 918-1 (a
presence entry in the pattern of occurrence of variable D 916).
Alternatively, a respective instance or entry for the compound
variable 920, such as compound variable 920-2, may correspond to an
absence if variable A is absent during a first time interval 912-2
(an absence entry in the pattern of occurrence of variable A 914)
and/or variable D is absent during a second time interval 918-2 (an
absence entry in the pattern of occurrence of variable D 916).
[0143] In an exemplary embodiment, entries for the pattern of
occurrence of variable A 914 during the first time interval 912 and
the pattern of occurrence of variable D 916 during the second time
interval 918 may be categorical or may be converted from
quantitative to categorical by partitioning using one or more
thresholds. In some embodiments, different thresholds may be used
for different variables. In some embodiments, one or more compound
variables may be a weighted summation of one or more variables. The
resulting one or more compound variables may be converted into
categorical data using one or more thresholds and/or one or more
quantitative variables may be converted into categorical data using
one or more thresholds prior to generating one or more compound
variables using a weighted summation.
[0144] Note that entries in the patterns of occurrence for
categorical variables are typically represented by codes. For
categorical variables having two class or categories, a single
binary digit may be used, such as 0 or 1, or -1 or 1. When there
are more than two categories, such as with ordered categorical
variables, a dummy variable having K values or bits may be used.
Entries for the compound variable 920 may determined by performing
an operation and/or a logical operation on corresponding entries in
the pattern of occurrence of the variable A 914 and the pattern of
occurrence of the variable D 916. The operation may include
multiplication. The logical operation may include a Boolean
operation, such as AND. A wide variety of coding approaches,
however, may be used in different embodiments for representing
presence and absence information in the pattern of occurrence of
variable A 914 and the pattern of occurrence of variable D 916.
Therefore, in some embodiments the logical operation may include
AND, OR, NOT, XOR, as well as combinations of these operations.
[0145] While FIG. 9A illustrates two variables, in some embodiments
3 or more variables may be used to determine the pattern of
occurrence (including presence and absence information) for the
compound variable 920. While a respective variable has a
corresponding time interval and offset (which may be zero or
finite), in some embodiments at least two variables may have time
intervals having the same duration and/or the same offset.
Similarly, while FIG. 9A illustrates 2 temporal onsets 910, in some
embodiments there may be one temporal onset 910 or 3 or more
temporal onsets 910, which may be used in determining the pattern
of occurrence of the compound variable 920.
[0146] FIG. 9B is a block diagram illustrating an embodiment 950
that summarizes the determining of compound variables. Logical
operations are performed on the patterns of occurrence of one or
more subsets of variables, such as variable A (during time interval
I) 960 and variable B (during time interval II) 962, and variable D
(during time interval I) 964, variable A (during time interval II)
966 and variable B (during time interval II) 962.
[0147] A number of variables included in determining a respective
compound variable is henceforth referred to as an order n. FIG. 9B
illustrates determination of a compound variable of order 2 and a
compound variable of order 3. In some embodiments, a respective
variable during a time interval, such as variable D (during time
interval I) 964, may be included once in determining a respective
compound variable, i.e., multiple instances of the respective
variable during the time interval may not be included in
determining the respective compound variable. However, the
respective variable may be included more than once in determining
the respective compound variable if different time intervals are
used, such as variable A (during time interval I) 960 and variable
A (during time interval II) 966. In some embodiments, there may be
additional or fewer variables, i.e., the order may be 1 (a
respective compound variable is merely a variable) or 4 or more. In
some embodiments, time interval I may correspond to a duration of
24 hours with an offset 924 (FIG. 9A) of zero from the temporal
onsets 910 (FIG. 9A). Time interval II may correspond to a duration
of 24 hours with an offset 924 (FIG. 9A) of 48 or 72 hours from the
temporal offsets 910 (FIG. 9A). In some embodiments, there may be
additional or fewer variables included in a respective compound
variable, and/or there may be fewer or additional time
intervals.
[0148] Referring back to FIG. 9A, as discussed further below one or
more statistical relationships between the patterns of occurrence
of one or more compound variable, such as compound variable 920,
and/or the pattern of occurrence of one or more of the variables,
such as variable A 914, and the temporal onsets 910 may be
determined. In the case of migraines, however, one or more temporal
onsets 910 corresponding to one or more rebound headaches, one or
more recurrence headaches, and/or one or more tension headaches may
be excluded during the determining of the one or more statistical
relationships. This may improve the results of the statistical
analysis. For example, the one or more rebound headaches may be
identified in accordance with a medicine usage history for
pharmacological agents, such as analgesics and/or triptans. In some
embodiments, the one or more rebound headaches may be identified,
at least in part, if there is no pain-free period between migraines
attacks.
[0149] In addition, entries in the pattern of occurrence of one or
more variables that occur during the duration of an event, such as
a migraine, may be excluded in determining one or more compound
variables and/or one or more statistical relationships. The reason
for this exclusion operation may be that such entries,
corresponding to the presence of one or more variables, may not
trigger an event since an event is already occurring. Said
differently, it may not be possible to initiate something that is
already occurring. FIG. 10 is a block diagram illustrating an
embodiment 1000 with a variable D 916-2 occurring during a duration
1010 of a migraine. As a consequence, the presence of variable D
916-2 may be excluded from the determining of compound variable 920
(FIG. 9A) and/or one or more statistical relationships, such as
those between temporal onsets 910 and the pattern of occurrence of
the compound variable 920 (FIG. 9A) and/or between temporal onsets
910 and the pattern of occurrence of variable D 916. Note that the
temporal onset 910-1 is illustrated as occurring during a time
interval 1014. In some embodiments, the temporal onset 910-1
corresponds to an onset time (i.e., a specific time). In alternate
embodiments, the duration 1010 may be defined with respect to a
beginning of the time interval 1014, a center of the time interval
1014, or the onset time corresponding to the temporal onset 910-1.
Embodiment 1000 also illustrates a threshold 1012 that may be used
to convert a quantitative variable into a categorical variable by
partitioning. In other embodiments, one or more thresholds may
include one or more geographic directions. While embodiments 900
(FIG. 9A) and 1000, illustrate variables, such as the variable D
916, occurring in time intervals 912 (FIG. 9A), 918 (FIG. 9A) and
1014 preceding corresponding temporal onsets 910, in some
embodiments one or more occurrences of one or more of the variables
in one or more time intervals corresponding to one or more temporal
onsets 910, i.e., one or more time intervals containing both a
respective temporal onset and at least a respective variable, may
be included when determining one or more of the statistical
relationships.
[0150] A wide variety of computational techniques may be used to
determine the one or more statistical relationships, including one
or more parametric analysis techniques, one or more non-parametric
analysis techniques, one or more supervised learning techniques
and/or one or more unsupervised learning techniques. In some
embodiments, one or more non-parametric analysis techniques may be
used. As noted previously, non-parametric analysis techniques make
few assumptions about an existence of a probability distribution
function, such as a normal distribution, corresponding to a
population from which samples or entries are obtained, or regarding
independence of the variables and/or the compound variables. In
general, non-parametric analysis techniques may use rank or
naturally occurring frequency information in the data to draw
conclusions about the differences between populations.
[0151] The one or more non-parametric analysis techniques may
perform hypothesis testing, i.e., to test a statistical
significance of a hypothesis. In particular, the one or more
non-parametric analysis techniques may determine if the one or more
temporal onsets and the one or more compound variables and/or one
or more variables are statistically independent (or dependent) in
accordance with a statistical significance criterion. One or more
variables and/or one or more compound variables having a
statistically significant relationship with the temporal onsets may
be used to identify one or more association variables. In the case
of migraines, the one or more association variables may be migraine
triggers or potential migraine triggers.
[0152] In exemplary embodiments, the non-parametric analysis
technique may include a chi-square analysis technique, a
log-likelihood ratio analysis technique (also referred to as
G-test), and/or a Fisher's exact probability analysis technique. In
addition to their other advantages, these techniques may be well
suited to analyzing an underdetermined problem (i.e., sparse
sampling in a multi-dimensional variable space), in which there may
be a plurality of variables and/or compound variables and a limited
number of entries or samples.
[0153] The chi-square analysis technique, the log-likelihood ratio
analysis technique, and the Fisher's exact probability analysis
technique may be determined using a cross-tabulation or contingency
tables (sometimes referred to as bivariate tables). The Fisher's
exact probability analysis technique computes the sum of
conditional probabilities of obtaining the observed frequencies in
a respective contingency table and the conditional probabilities of
obtaining exactly the same observed frequencies for any
configuration that is more extreme (i.e., having a smaller
conditional probability). The chi-square (.chi..sup.2) may be
determined using .chi. 2 = i .times. .times. ( O i - E i ) 2 E i ,
##EQU1## and the log-likelihood ratio (LLR) using LLR = i .times.
.times. O i .times. .times. ln .function. ( O i E i ) , ##EQU2##
where the summation is over the entries in the respective
contingency table, O.sub.i is the i-th observed frequency value,
and E.sub.i is the i-th expected frequency value. The following
example illustrates an embodiment of determining a statistical
relationship using the log-likelihood ratio.
[0154] Consider the data in Table IV. The first column contains the
number of entries in the pattern of occurrence where a variable or
compound variable is present during a time interval, such as the
first time interval 912 (FIG. 9A), and a temporal onset is present
after a time offset, such as the time offset 924 (FIG. 9A)
(henceforth denoted by X.sub.11) plus the number of entries in the
pattern or occurrence where the variable or compound variable is
absent during the time interval and a temporal onset is absent
after the time offset (henceforth denoted by X.sub.00). X.sub.11 is
sometimes referred to as a true-true and X.sub.00 is sometimes
referred to as a false-false. X.sub.11 and X.sub.00 are henceforth
referred to as co-occurrences.
[0155] The second column contains the number of entries in the
pattern of occurrence where the variable or compound variable is
present during the time interval and a temporal onset is absent
after the time offset (henceforth denoted by X.sub.10) plus the
number of entries in the pattern of occurrence where the variable
or compound variable is absent during the time interval and a
temporal onset is present after the time offset (henceforth denoted
by X.sub.01). X.sub.10 is sometimes referred to as a true-false and
X.sub.01 is sometimes referred to as a false-true. X.sub.10 and
X.sub.01 are henceforth referred to as cross occurrences.
TABLE-US-00004 TABLE IV An embodiment of a contingency table.
Number of Co-Occurrences Number of Cross Occurrences (X.sub.11 +
X.sub.00) (X.sub.10 + X.sub.01) 46 11
[0156] If the variable or the compound variable and the temporal
onsets are completely independent, the expected frequency values
for each column, E.sub.1 and E.sub.2, would equal 28.5, one half of
the sum of the number of co-occurrences and cross-occurrences,
i.e., the total number of observations (data points or samples) in
Table IV. Therefore, for Table IV LLR = 2 46 .times. .times. ln
.function. ( 46 28.5 ) + 2 11 .times. .times. ln .function. ( 11
28.5 ) = 44.04 - 20.94 = 23.10 . ##EQU3## A one-sided minimal
statistical significance confidence criterion of 5% (.alpha.=0.05)
or statistical confidence threshold based on the number of degrees
of freedom (the size of the contingency table) corresponds to an
LLR of 3.841. Since the LLR for Table IV is greater than 3.841, it
is statistically significant. From a statistical significance
perspective, therefore, the temporal onsets and the pattern of
occurrence of the variable or compound variable in this example are
dependent. Note that the determination of the statistical
relationship for the temporal onsets and the variable or the
compound variable in this embodiment uses presence and absence
information in the pattern of occurrence of the variable or
compound variable. In some embodiments, one or more of the
statistical relationships may be determined using presence
information, i.e., the presence of one or more variables or one or
more compound variables during one or more time intervals, without
using absence information. In alternate embodiments, a wide variety
of analysis techniques may be used to determine the one or more
statistical relationships, including one or more non-parametric
analysis techniques and one or more parametric analysis
techniques.
[0157] In parametric analysis, a Pearson's product-moment
correlation coefficient r may be useful in summarizing a
statistical relationship. For some contingency tables, Cramer's phi
.phi., the square root of .chi..sup.2 or the LLR divided by the
number of observations N, may have a similar interpretation to r
(although, it is known that Cramer's phi .phi. may underestimate
r). In the example illustrated in Table IV, .phi. = LLR N = 23.1 57
= 0.64 . ##EQU4##
[0158] The chi-square analysis technique and the log-likelihood
ratio analysis technique may have a maximal sensitivity for
contingency tables based on patterns of occurrence of variables or
compound variables having 50% presence entries and 50% absence
entries. In addition, in embodiments where temporal onsets, such as
temporal onsets 910 (FIG. 9A), correspond to onsets during one or
more time windows or time intervals, maximal sensitivity may occur
if 50% of these time windows or time intervals have a temporal
onset (i.e., a presence entry). In some embodiments, one or more
contingency tables may be generated to achieve approximately 50%
presence entries for patterns of occurrence of one or more
variables or one or more compound variables, and/or 50% temporal
onsets by using a subset of the collected information or data. In
an exemplary embodiment, one or more contingency tables may be
generated by approximately randomly (including the use of a
pseudo-random number generator or algorithm) selecting a subset of
the temporal onsets, and/or approximately randomly selecting a
subset of the presence or absence entries of one or more patterns
of occurrence of one or more variables or one or more compound
variables such that the one or more contingency tables may have
approximately 50% presence entries and 50% absence entries
distributed over X.sub.00, X.sub.11, X.sub.10, and X.sub.01. For
infrequently occurring events, variables, and/or compound
variables, there may be more absence entries than presence entries
in the collected data or information. As a consequence, different
sampling ratios may be used for presence and absence entries.
[0159] In some embodiments, boosting may be used when generating
one or more contingency tables. The fraction of the collected
information may be approximately randomly sampled to generate one
or more contingency tables. A respective contingency table may be
generated N times using approximate random sampling. Statistical
relationships for at least M of these N contingency tables may be
used (including combining and/or averaging) to determine whether or
not the temporal onsets and the corresponding variable or compound
variable are independent. In an exemplary embodiment, N may be 5,
10, 25, 50, 100 or more. M may be 50% (rounded to the nearest
integer), 60%, 66%, 70%, 75%, 80% or more of N.
[0160] In some embodiments, there may be too few presence entries
or too many presence entries in one or more patterns of occurrence
of one or more variables or compound variables to reliably
determine statistically significant independence (or dependence)
from the temporal onsets. As a consequence one or more of these
variables or one or more of these compound variables may be
excluded when determining one or more statistical relationships. In
an exemplary embodiment, one or more variables or one or more
compound variables having patterns of occurrence with less than 10%
presence entries or more than 85% presence entries may be excluded.
To assist in obtaining sufficient presence and absence entries, in
some embodiments at least the first individual may be instructed to
vary their activities and/or diet from day to day during the data
collection time interval.
[0161] Overfitting is a risk when developing a model in a
statistical learning problem. In some embodiments, this risk may be
addressed by using a fraction or percentage of the collected data
or information (patterns of occurrence and temporal onsets) for
training, i.e., to develop the model, and a remainder for testing
the resulting model. This is illustrated in FIG. 11, which is a
block diagram illustrating an embodiment 1100 of determining model
complexity. In some embodiments, the model complexity may
correspond to a number of variables or compound variables that have
statistically significant dependence on the temporal onsets. In
some embodiments, the model complexity may, at least in part,
correspond to a number of variables included in a respective
compound variable, i.e. the order n. Embodiment 1100 shows a
magnitude of a training and/or a test error 1112 as a function of
model complexity 1110. A training error 1114 typically decreases as
the model complexity 1110 increases (the model better fits or
predicts a training set of data). A test error 1116 typically
exhibits a minimum. Additional model complexity 1110 beyond this
point does not generalize well (the model offers a poorer fit or
prediction for a test set of data). Beyond this point, therefore,
the training set of data may be overfit 1118. In an exemplary
embodiment, the percentage of the collected information used for
training may be 70%, 75%, 80%, 85% or 90%.
[0162] An additional metric of the model complexity may be
determined. This metric may be used in conjunction with or
independently of the training set of data and the test set of data.
The additional metric is described below. In some problems and/or
embodiments, determining one or more statistical relationships for
one or more variables (or, said differently, one or more compound
variables of order 1) may not be sufficient to determine
statistically significant independence (or dependence) with respect
to the temporal onsets. For example, in multi-dimensional problems,
where exposure to two or more variables in at least close temporal
proximity may be necessary to initiate a temporal onset (such as a
migraine), a value of the Fisher's exact probability, .chi..sup.2,
and/or LLR for a compound variable of order 1 may be reduced since
there is a penalty for the presence of the cross occurrences,
X.sub.10 and X.sub.01.
[0163] More generally, the value of the Fisher's exact probability,
.chi..sup.2, and/or LLR may be reduced if the order n of one or
more compound variables is less than an intrinsic order of the
multi-dimensional problem. In the case of X.sub.10, a temporal
onset may or may not occur unless a certain number of variables or
a set of variables (which may be inter-operative) are present in
close temporal proximity. And in the case of X.sub.01, more than
one set of variables may be present, i.e., one or more variables in
another set of variables may have triggered the corresponding
temporal onsets. As illustrated in FIG. 7, in the embodiments for
migraines there may also be variations in a patient's sensitivity
threshold to a variable or one or more sets of variables as a
function of time.
[0164] To assess whether or not the model has sufficient
complexity, i.e., whether or not one or more compound variables
have been determined to sufficient order n, a ratio R may be
determined. R is defined as X.sub.11 divided by the total number of
occurrences of the variable or compound variable of order n, i.e.,
R = X 11 ( X 11 + X 10 ) . ##EQU5## An increasing value of R,
and/or Cramer's phi .phi., as statistical analysis is performed to
higher order (i.e., n+1) may be metrics of goodness, i.e., it may
indicate that the higher order does a better job determining
statistically significant independence or dependence between one or
more compound variables and the temporal onsets. In some
embodiments, contingency tables for one or more compound variables
may be generated for progressively higher orders. Once the ratio R
is close to or equal to one, i.e., X.sub.10 is close to or equal to
zero, further increases in the order of one or more compound
variables may not be needed, i.e., the model has sufficient
complexity.
[0165] One or more variables and/or compound variables having
statistically significant statistical relationships with the
temporal onsets may be identified as one or more association
variables. For a respective compound variable or order n having a
significant statistical relationships with the temporal onsets, the
n constituent variables may be identified as n association
variables and/or as a set of association variables. In some
embodiments, one or more statistically significant compound
variables of order n having the ratio R approximately equal to 1
may be identified as one or more association variables. In the
embodiments for migraines, one or more association variables may be
one or more migraine triggers or one or more probable migraine
triggers.
[0166] In some embodiments one or more compound variables of order
n and/or one or more constituent variables in the one or more
compound variables of order n may be ranked in accordance with the
corresponding determined statistical relationships that are
statistically significant. In some embodiments, a ranking of a
respective constituent variable is in accordance with a number of
occurrences of the respective constituent variable in one or more
compound variables of order n having statistical relationships that
are statistically significant. Ranking may be performed as the
statistical significance confidence criterion (.alpha.) is
progressively increased.
[0167] In exemplary embodiments, .alpha. may be 0.05 or lower. For
a respective ranking, a pareto corresponding to at least a subset
of the respective ranking may be defined. The pareto may correspond
to variables or compound variables having a statistical
relationship or a number of occurrences exceeding a threshold. In
some embodiments, a top 10, 20, 50 or 100 variables or compound
variables may be used, or a plurality of the top 10, 20, 50 or 100
variables or compound variables may be used. For compound variables
of order n, approximate stability of the pareto as the statistical
significance confidence criterion is increased may be used to
identify a noise floor. Approximately stability may include an
approximately unchanged order n in the ranking or a presence of
approximately the same variables (for example, more than 70%) in
the ranking. In exemplary embodiments, the noise floor may
correspond to an .alpha. of 0.01 or lower, an .alpha. of 0.001 or
lower, or an .alpha. of 0.0001 or lower. One or more variables
and/or one or more compound variables in paretos corresponding to
one or more statistical significance confidence criteria that
exceed the noise floor may be identified as association
variables.
[0168] In some embodiments, one or more variables and/or one or
more compound variables in paretos corresponding to one or more
statistical significance confidence criteria that exceed the noise
floor may be used as a seed set in a subsequent statistical
analysis. The subsequent statistical analysis may determine
statistical relationships for compound variables of a higher order.
In some embodiments, the subsequent analysis may utilize an
analysis technique such as SVM or CART. These and other analysis
techniques are discussed further below.
[0169] FIG. 12 is a block diagram illustrating an embodiment of
ranking variables 1200. Statistical relationship value 1212 is
plotted as a function of statistical significance 1210, such as the
statistical significance confidence criteria. Several rankings 1222
are illustrated. Ranking 1222-1, including variable F (during time
interval IV) 1214 and variable M (during time interval II) 1216, is
below a noise floor 1218. Ranking 1222-2 and ranking 1222-3 are
above the noise floor 1218. A subset 1220 of ranking 1222-2 and
ranking 1222-3 is stable. The subset 1220 may identified as the
pareto.
[0170] In an exemplary embodiment for migraines, the noise floor
1218 corresponds to an .alpha. of approximately 0.001. At least 8
of the top-10 variables in paretos for more stringent statistical
significance confidence criteria than that corresponding to the
noise floor 1218 are present even when an approximately random
subset corresponding to 80% of the patterns of occurrence and the
temporal onset data is used. Excluding probable recurrence
headaches, rebound headaches and tension headaches increases the
statistical relationship values 1212 for compound variables having
an order n corresponding to the pareto. Compound variables of at
least order 4 have ratio R values approximately equal to 1.
[0171] Having identified one or more association variables for at
least the first individual, one or more additional association
variables may identified. For example, if one or more groups of
association variables have been previously determined for one or
more other individuals, the one or more association variables
identified for at least the first individual may be used to
associate at least the first individual with one or more of these
groups. In this way, one or more of the association variables in
one or more of the groups may be identified as additional
association variables for at least the first individual. For
example, the one or more additional association variables may be
groups of migraine triggers and at least the first individual may
be associated (classified) with one or more of these groups in
accordance with one or more identified migraine triggers for at
least the first individual.
[0172] Alternatively, additional association variables may be
identified by associating the identified one or more association
variables for at least the first individual with previously
determined groups of variables. For example, the identified one or
more association variables for at least the first individual may be
foods and additional association variables may be identified by
associating the foods with corresponding food groups, such as
pine-apple, mushroom, melon, cashew, banana, or citrus, or groups
determined based on an amount of constituent elements (minerals,
fats, carbohydrates, and/or proteins) in foods. For example, if an
identified association variable is in the beet family or the citrus
family, other members of the beet or citrus families may be
identified as association variables.
[0173] FIG. 13 is a block diagram illustrating an embodiment 1300
of associating one or more variables with one or more groups of
variables. Group I 1310 may include variable A 1314, variable F
1316, associated variable S 1318, and variable C 1320. Group II
1312 may include variable C 1320 and a compound variable 1322,
including variable A (during time interval III) plus variable D
(during time interval I). If a variable, such as variable A 1314,
is determined or identified, one or more of the other variables in
group I 1310 may be identified. In some embodiments, there may be
additional groups, there may or may not be overlap (such as
variable C 1320) between two or more of the groups, and/or a
respective group may include fewer or more variables, fewer or more
associated variables, and/or fewer or more compound variables.
[0174] Having identified one or more association variables in
accordance with one or more statistical relationships, rankings,
and/or associated groups of associated variables, one or more
recommendations and/or one or more reports may be provided to at
least the second individual and/or at least the first individual.
In an exemplary embodiment, the one or more recommendations may
include a listing of one or more migraine triggers and/or one or
more probable migraine triggers for at least the first individual.
The one or more recommendations may include one or more variables
for which the statistical analysis was unable to determine a
statistically significant relationship. In some embodiments, the
one or more recommendations may indicate one or more migraine
triggers and/or one or more probable migraine triggers that at
least the first individual may wish to modify (such as for
behaviors) and/or avoid. The one or more recommendations may
indicate additional analysis that may be advisable in accordance
with one or more of the statistical relationships and/or the one or
more association variables. One or more corresponding reports may
include the one or more recommendations. The one or more reports
may include a summary for at least the first individual. The
summary may include a health overview for at least the first
individual during at least a portion of the data-collection time
interval. In the case of migraines, the health overview may include
a summary of migraine frequency, migraine severity and/or the use
of one or more pharmacological agents, such as one or more acute
therapies and/or one or more preventive therapies.
[0175] In some embodiments, the one or more recommendations may
include placebo information, for example, placebo migraine
triggers. After this placebo information is provided to at least
the first individual (possibly via an intermediary such as at least
the second individual), an impact on at least the first individual
may be determined. For example, migraine frequency, migraine
severity, and/or use of pharmacological agents during a subsequent
time interval may be determined. An efficacy of the identified
association variables may be determined by comparing these metrics
with those that occur when non-placebo information is used, i.e.,
when actual association variables are provided to at least the
first individual. The difference of these two metrics can be used
to define a therapeutic gain. In some embodiments, the therapeutic
gain may be determined by averaging results for two or more
individuals such as at least the first individual.
[0176] Attention is now given to other techniques of performing
statistical analysis, such as determining the one or more
statistical relationships. As discussed previously, one or more
variables or one or more compound variables determined during the
statistical analysis, for example, in one or more paretos, may be
used in subsequent analysis. In some embodiments, the subsequent
analysis may utilize a non-parametric analysis technique as an
initial or first stage. In other embodiments, the subsequent
analysis may not utilize a non-parametric analysis technique. The
subsequent analysis may be used as the initial or first stage, to
refine the model (including adding or removing one or more
variables and/or one or more compound variables), and/or identify
one or more association variables. The subsequent analysis may
include classification and/or regression (such as determining a
model of the temporal onsets including one or more variables and/or
one or more compound variables with corresponding weights). As with
the initial statistical analysis, a wide variety of techniques may
be used in the subsequent analysis. Two such techniques, SVM and
CART, are described further below.
[0177] Embodiments of SVM are instances of supervised learning
techniques that may be applied to classification and regression
problems. For binary classification, a set of binary labeled data
points (training data or examples) is provided. SVMs may be used to
determine an optimal separation boundary, defined by the variables
and/or compound variables, between two classes of data points. A
separation boundary is optimal if using it as a decision rule to
classify future data points minimizes an expected classification
error. For linearly separable data sets (i.e., a class of absences,
which may be indicated by -1, and a class of presences, which may
be indicated by +1, may be separated by a line in 2 dimensions, or
a so-called hyperplane in higher dimensions), SVMs may be used to
determine a maximal margin hyperplane. For the maximal margin
hyperplane, a linear decision boundary may be positioned such that
it separates both classes and such that the distance to the closest
point from each class is maximized. For non-linearly separable data
sets, some training data points may be allowed on the opposite or
"wrong" side of the hyperplane, i.e., a classification error on the
training data set may be allowed and may be minimized, while the
margin, measured between points on the "correct" side of the
hyperplane, is maximized.
[0178] If a linear decision boundary is not sufficiently
complicated to model the separation between classes accurately, the
corresponding linear model may be transformed into a non-linear
model by non-linearly transforming the variables and/or compound
variables into a possibly higher dimensional Euclidean space. A
linear decision boundary constructed in such a higher dimensional
Euclidean space may correspond to a non-linear decision boundary in
the original space of variables and/or compound variables. This
approach is referred to as kernel SVM.
[0179] Depending on how the margin and training error are measured,
and how a trade-off between maximizing the margin and minimizing
the training error is established, different types of SVMs may be
obtained. In some embodiments, SVM may include standard 1-norm SVM
(measuring the margin using Euclidean distance, i.e., a
L.sub.2-norm, and the training error using a L.sub.1-norm),
standard 2-norm SVM (measuring the margin using Euclidean distance,
i.e., the L.sub.2-norm, and the training error using the
L.sub.1-norm), and/or LP-SVM (measuring the margin using the
L.sub.1-norm and the training error using the L.sub.1-norm). Each
of these 3 types of SVM may be a C-type or nu-type SVM. These two
varieties correspond to different ways of trading-off maximizing
the margin against minimizing the training error. The 1-norm SVM,
standard 2-norm SVM, and/or LP-SVM may be a C+/C- or nu+/nu- type
(when errors on positive (+1) labeled training data are weighted
differently than errors on negative (-1) labeled training
data).
[0180] The principle for binary classification described above may
be extended to regression, for example, by copying the regression
data twice, shifting both copies in opposite directions (over a
distance epsilon) with respect to the continuous output dimension
or variable and establishing a regression surface as a decision
boundary between the two shifted copies that may be regarded as two
classes for binary classification. As a consequence, in some
embodiments, regression versions of SVMs corresponding to
previously described SVMs may be used.
[0181] The decision boundary determined using one or more SVMs may
be used to discriminate between temporal onsets and non-temporal
onsets. For binary classification, measures of goodness for the
resulting model include a prediction accuracy that is better than
predicting 50% of the positive data (i.e., occurrences, which may
be indicated by a +1) as positive (i.e., true positive predictions)
and better than predicting 50% of the negative data (i.e.,
absences, which may be indicated by a -1) as negative (i.e., true
negative predictions). Doing better than 50/50 corresponds to doing
better than random. In an exemplary embodiment, the resulting model
successfully predicts at least 80-85% of the true-false (X.sub.10)
and false-false events (X.sub.00), i.e., the true negatives, while
predicting significantly more than 50% of the true positives
correctly, i.e., false-true (false-true (X.sub.01) and true-true
events (X.sub.11)).
[0182] CART is non-parametric multivariate analysis technique. It
involves the determination of a binary decision tree using the
training set of data. Predictions based on the resulting tree may
be compared to the test set of data (cross validation). A decision
tree provides a hierarchical representation of the feature space in
which explanatory variables are allocated to classes (such as
temporal onsets or non-temporal onsets) according to the result
obtained by following decisions made at a sequence of nodes at
which branches of the tree diverge. Branches or divisions of the
tree may be chosen to provide the greatest reduction in the entropy
of the variables (for a classification tree based on categorical
data), such as a small or zero standard deviation, or the greatest
reduction in the deviation between the variables (and/or compound
variables) and one or more variables being fit (for a regression
tree based on quantitative data). A tree stops growing when no
significant additional reduction can be obtained by division. A
node that is not further sub-divided is a terminal node. It is
associated with a class. A desirable decision tree is one having a
relatively small number of branches, a relatively small number of
intermediate nodes from which these branches diverge, terminal
nodes with a non-zero number of entries, and high prediction power
(correct classifications at the terminal nodes). In some
embodiments, CART may be used in conjunction with a gradient
boosting algorithm, where each boosted tree is combined with its
mates using a weighted voting scheme. Gradient boosting may be used
to force the binary decision tree to classify data that was
previously misclassified.
[0183] As noted above, a wide variety of statistical analysis
techniques may be used to determine the one or more statistical
relationships. These may include one or more supervised learning
techniques, one or more unsupervised learning techniques, one or
more parametric analysis techniques (such as a Pearson's
product-moment correlation coefficient r or an inner product),
and/or one or more non-parametric analysis techniques.
Non-parametric analysis techniques may include a Wilcoxon matched
pairs signed-rank test (for ordinal or ranked data), a
Kolmagorov-Smirnov one-sample test (for ordinal or ranked data), a
dependent t-test (for interval or ratio data), a Pearson
chi-square, a chi-square test with a continuity correction (such as
Yate's chi-square), a Mantel Heanszel chi-square test, a
linear-by-linear association test, a maximum likelihood test, a
risk ratio, an odds ratio, a log odds ratio, a Yule Q, a Yule Y, a
phi-square, a Kappa measure of agreement, a McNemar change test, a
Mann Whitney U-test, a Spearman's rank order correlation
coefficient, a Kendall's rank correlation, a Krushcal-Wallis
One-Way Analysis of Variance, and a Turkey's quick test.
[0184] Supervised learning techniques may include least-squares
regression (including correlation), ridge regression, partial
least-squares (also referred to as partial correlation), a
perceptron algorithm, a winnow algorithm, linear discriminant
analysis (LDA), Fisher discriminant analysis (FDA), logistic
regression (LR), a Parzen windows classifier, a (k-)
nearest-neighbor classification, multivariate adaptive regression
splines (MARS), multiple additive regression trees (MART), SVM,
LASSO (a regularized linear regression technique like ridge
regression, but with L.sub.1-norm regularization of the
coefficients), least angle regression (LARS), decision trees (such
as CART, with and without gradient boosting, such as ID3 and C4.5),
bagging, boosting (such as, adaboost) of simple classifiers, kernel
density classification, a minimax probability machine (MPM),
multi-class classification, multi-label classification, a Gaussian
Process classification and regression, Bayesian statistical
analysis, a Naive Bayes classifier, and neural networks for
regression and classification. While some of these supervised
learning algorithms are linear, it should be understood that one or
more additional non-linear versions may be derived using the same
"kernel-methodology", as previously described for the SVM, leading
to a spectrum of kernel-based learning methods, for example, kernel
FDA, kernelized logistic regression, the kernelized perceptron
algorithm, etc. One or more of these non-linear versions may be
used to perform the statistical analysis.
[0185] Unsupervised learning techniques may include a kernel
density estimation (using, for example, Parzen windows or k-nearest
neighbors), more general density estimation techniques, quantile
estimation, clustering, spectral clustering, k-means clustering,
Gaussian mixture models, an algorithm using hierarchical
clustering, dimensionality reduction, such as principal component
analysis or PCA, multi-dimensional scaling (MDS), isomap, local
linear embedding (LLE), self-organizing maps (SOM), novelty
detection (also referred to as single-class classification, such as
single-class SVM or single-class MPM), canonical correlation
analysis (CCA), independent component analysis (ICA), factor
analysis, and/or non-parametric Bayesian techniques like Dirichlet
processes. As noted above for the supervised learning techniques,
one or more additional non-linear versions of one or more linear
unsupervised learning techniques may be used to perform the
statistical analysis, such as kernel PCA, kernel CCA and/or kernel
ICA.
[0186] In some embodiments, at least a portion of the statistical
analysis, such as determination of one or more statistical
relationships and/or identification of one or more association
variables may include spectral analysis. For example, a Fourier
transform or a discrete Fourier transform may be performed on the
temporal onsets, one or more patterns of occurrence of one or more
variables, and/or one or more patterns of occurrence of one or more
compound variables. Analysis in the frequency domain may allow
patterns in at least some of the data, such an impact of a woman's
menstrual cycle, to be determined.
[0187] In some embodiments, determination of one or more
statistical relationships and/or identification of one or more
association variables may include the use of design of
experiments.
[0188] In some embodiments, at least a portion of the statistical
analysis and/or identification of one or more association variables
may be implemented using one or more filters, including analog
filters, digital filters, adaptive filters (using, for example, a
least square error or gradient approach, such as steepest decent),
and/or neural networks. The one or more filters may be implemented
using one or more DSPs. In some embodiments, the statistical
analysis and/or identification of one or more association variables
may be implemented in hardware, for example, using one or more
ASICs, and/or software.
[0189] FIG. 14 is a block diagram illustrating an embodiment of a
signal processing circuit 1400 for determining one or more
statistical relationships and/or identifying one or more
association variables. Presence (coded with 1s) and absence
information (coded with -1s) for one or more variables 1410 are
selectively coupled using selection circuit 1416 to one or more
filters H.sub.i 1418. The selection circuit 1416 may be a
multiplexer. The filters H.sub.i 1418 may perform spectral
modification, such as limiting one or more of the variables 1410 to
one or more time intervals, or one or more sequences of time
intervals. The filters H.sub.i 1418 may convert the presence and
absence information for one or more of the variables 1410 into one
or more patterns of occurrence.
[0190] The filters H.sub.i 1418 may be adaptive. The adaptation may
be in accordance with temporal onsets 1412 and/or an error 1426.
The adaptation may include one or more time intervals, such as the
first time intervals 912 (FIG. 9A), and/or one or more offsets,
such as the offset 924 (FIG. 9A). In some embodiments, the
adaptation may minimize or reduce the error 1426 or a portion of
the error 1426. In the embodiments for migraine, for example, the
adaptation may reduce a predicted number of migraines, a predicted
severity and/or a predicted frequency.
[0191] Outputs from one or more of the filters H.sub.i 1418 may be
coupled to filter H.sub.B 1420. The filter H.sub.B 1420 may perform
additional spectral modification. As a consequence, an arbitrary
filtering operation may be implemented using one or more of the
filters H.sub.i 1418 and/or the filter H.sub.B 1420. The filter
H.sub.B 1420 may determine a pattern of occurrence for one or more
variables 1410 and/or one or more compound variables.
[0192] The temporal onsets 1412 may be filtered using filter
H.sub.3 1418-3. Comparisons between an output of filter H.sub.3
1418-3 and an output of the filter H.sub.B 1420 may be performed
using statistical analysis element 1424. In some embodiments, the
statistical analysis element 1424 may be a comparator. Statistical
analysis element may implement one or more statistical analysis
techniques, such as the log likelihood ratio. The statistical
analysis element 1424 may generate the error 1426. The error 1426
may be a scalar, a vector, or a matrix. In some embodiments, the
statistical analysis element 1424 may perform a relative time
shifting of the output of filter H.sub.3 1418-3 and the output of
the filter H.sub.B 1420. In an exemplary embodiment, the
statistical analysis element 1424 may determine one or more
statistical relationships between the temporal onsets 1412 and one
or more patterns of occurrence of one or more variables and/or one
or more compound variables. The one or more statistical
relationships may be determined sequentially and/or substantially
concurrently. The error 1426 may correspond to the one or more
statistical relationships.
[0193] In some embodiments, one or more optional additional inputs,
such as optional additional input 1414, may be filtered using one
or more filters, such as filter H.sub.4 1418-4, and/or combined
with the temporal onsets 1412 using a filter, such as
filter/combiner H.sub.5 1422. An output from the filter/combiner
H.sub.5 1422 may be included in the analysis performed by the
statistical analysis element 1424. The one or more optional
additional inputs may allow inclusion of cross-terms. In some
embodiments, the one or more optional additional inputs may include
other disease symptoms and/or disease conditions.
[0194] While a single output is shown for the filter H.sub.B 1420,
there may be additional outputs that are used by the statistical
analysis element 1424. Similarly, there may be additional outputs
from the filter/combiner H.sub.5 1422 that are used by the
statistical analysis element 1424. While embodiment 1400 uses
presence and absence information in the one or more variables 1410,
the temporal onsets 1412, and the optional additional input 1414,
in some embodiments one or more of these items may only use
presence information. Embodiment 1400 may include fewer elements or
additional elements. A position of at least two elements may be
switched. Functions of two or more elements may be combined into a
single element.
[0195] Attention is now directed to embodiments of processes for
implementing the collection of information during the
data-collection time interval, the determining of one or more
statistical relationships, the identification of one or more
association variables, and/or the providing of recommendations to
at least the first individual and/or at least the second
individual. FIG. 15 is a flow diagram illustrating an embodiment
1500 of a process for collecting information. A device including a
set of pre-determined questions may be optionally provided (1510).
Configuration instructions may be optionally received (1512). A
subset of pre-determined questions may be asked, one or more times
during a time interval, in accordance with the configuration
instructions (1514). Answers may be optionally pre-selected in
accordance with an answer history and/or default answers (1516).
Answers to the subset of pre-determined questions may be received
one or more times during the time interval (1518). Answers to the
subset of pre-determined questions may be transmitted one or more
times during the time interval (1520). Operations in embodiment
1500 may be optionally repeated, one or more times (1522). The
process in embodiment 1500 may include fewer operations or
additional operations. A position of at least two operations may be
switched. Two or more operations may be combined into a single
operation.
[0196] FIG. 16 is a flow diagram illustrating an embodiment 1600 of
a process for determining one or more association variables.
Presence or absence of one or more variables may be optionally
determined in accordance with one or more thresholds (1610). A
subset of temporal onsets may be optionally identified (1612).
Pattern(s) of occurrence of one or more compound variables may be
determined (1614). Statistical relationship(s) between temporal
onsets or the subset of temporal onsets and the pattern(s) of
occurrence may be determined (1616). The compound variable(s) may
be optionally ranked in accordance with the statistical
relationship(s) (1618). The variables may be optionally ranked in
accordance with a number of occurrences of the variables in
statistically significant statistical relationships (1620). One or
more association variables or sets of association variables may be
identified (1622). One or more additional association variables may
be optionally determined or identified in accordance with the one
or more association variables (1624). Operations in embodiment 1600
may be optionally repeated one or more times (1626). The process in
embodiment 1600 may include fewer operations or additional
operations. A position of at least two operations may be switched.
Two or more operations may be combined into a single operation.
[0197] FIG. 17 is a flow diagram illustrating an embodiment 1700 of
a process for providing recommendation(s) and/or report(s).
Temporal onsets and pattern(s) of occurrence of one or more
variables may be transmitted (1714) from a client computer 1710 to
a server computer 1712. The temporal onsets and the pattern(s) of
occurrence of one or more variables may be received (1716). One or
more statistical relationships may be determined (1718). One or
more recommendation(s) and/or report(s) may be transmitted (1720)
from the server 1712 to the client computer 1710. The one or more
recommendation(s) and/or report(s) may be received (1722). The one
or more recommendations and/or report(s) may be presented (1724).
The process in embodiment 1700 may include fewer operations or
additional operations. A position of at least two operations may be
switched. Two or more operations may be combined into a single
operation.
[0198] FIG. 18 is a flow diagram illustrating an embodiment 1800 of
a process for providing one or more reports. A request for a report
may be optionally transmitted (1814) from a client computer 1810 to
a server computer 1812. The request for the report may be
optionally received (1816). One or more reports may be generated
(1818). The one or more reports may be transmitted (1820) from the
server 1812 to the client computer 1810. The one or more reports
may be received (1822). The one or more reports may be presented
(1824). The process in embodiment 1800 may include fewer operations
or additional operations. A position of at least two operations may
be switched. Two or more operations may be combined into a single
operation.
[0199] Attention is now directed to embodiments of data structures
that may be used in implementing the collection of information
during the data-collection time interval, the determining of one or
more statistical relationships, the identification of one or more
association variables, and/or the providing of one or more
recommendations and/or one or more reports to at least the first
individual and/or at least the second individual. FIG. 19 is a
block diagram illustrating an embodiment of a questionnaire data
structure 1900. The questionnaire data structure 1900 may include
one or more modules 1910. A respective module, such as module
1910-1, may include entries for one or more questions 1912, one or
more classifications 1914 for the questions 1912 (such as primary
or secondary, or general or specific), one or more default answers
1916, and/or one or more answer histories 1918. The questionnaire
data structure 1900 may include fewer or addition modules and/or
entries. A position of two modules and/or a position of two entries
may be switched. Two or more modules may be combined into a single
module. Two or more entries may be combined into a single
entry.
[0200] FIG. 20 is a block diagram illustrating an embodiment of a
data structure 2000. The data structure 2000 may include one or
more sets of categories. A respective set of categories may
correspond to at least the first individual. The respective set of
categories may include identification 2010 for at least the first
individual, meta data 2012 (such as relevant demographic, billing
and/or medical history data for at least the first individual),
configuration instructions 2014, temporal onsets 2016, variable(s)
2022, derived variable(s) 2024, compound variable(s) 2026,
statistical relationships 2028, optional rankings 2030, association
variable(s) 2032, group(s) of association variables 2034 and/or
recommendations/reports 2036. The temporal onsets 2016, the
variable(s) 2022, the derived variable(s) 2024, and/or the compound
variable(s) 2026 may include one or more entries including time
intervals 2018 and corresponding presence and/or absence
information 2020. The data structure 2000 may include fewer or
addition categories and/or entries. Two or more categories may be
combined into a single category. A position of two categories
and/or a position of two entries may be switched. Two or more
entries may be combined into a single entry.
[0201] Attention is now directed towards alternative applications
for the processes and apparatuses for collection of information,
determining one or more statistical relationships, identifying one
or more association variables, and providing one or more
recommendations and/or one or more reports. In some embodiments,
one or more fees may be charged for offering the service of
collecting the information and/or identifying one or more
association variables (such as one or more migraine triggers) for
at least the first individual. In some embodiments, the one or more
fees may be in accordance with a cost savings associated with a
reduced usage of one or more pharmacological agents (such as one or
more acute and/or preventive therapies). The one or more fees may
be collected from at least the first individual, at least the
second individual, and/or one or more insurance providers. In some
embodiments, information associated with the one or more identified
association variables may be sold to third parties. In some
embodiments, advertising may be presented to at least the first
individual and/or at least the second individual during the
collection of information, the providing of one or more
recommendations and/or the providing of one or more reports. Fees
may be charged to advertisers for such services.
[0202] In some embodiments, at least the first individual may be
associated with one or more groups, such as one or more groups of
migraine patients, in accordance with one or more identified
association variables (such as migraine triggers). A respective
group may be analyzed to determine one or more existing or new
acute and/or preventive therapies that may provide improved
efficacy for the respective group. Using migraine as an exemplary
embodiment, improved efficacy may include a reduction in migraine
frequency, a reduction in migraine severity, a reduction in
recurrence, a reduction in one or more adverse reactions or side
effects, a reduction in the use of one or more pharmacological
agents, and/or an improved efficacy in aborting one or more
migraine attacks relative to other acute and/or preventive
therapies.
[0203] In some embodiments, association with one or more groups
and/or analysis of the respective group may include statistical
analysis and/or determining a presence or an absence of one or more
biological markers, including genetic material, deoxyribonucleic
acid, ribonucleic acid, one or more genes, one or more proteins,
and/or one or more enzymes that may be common to the respective
group and/or two or more groups. The one or more biological markers
may be determined by testing one or more biological samples,
including a blood sample, a urine sample, a stool sample, a saliva
sample, a sweat sample, a mucus sample, a skin scrapping, and/or a
tear. The one or more biological samples may be analyzed using
chemical analysis, genetic analysis (such as genetic sequencing),
nuclear quadrapole resonance, nuclear magnetic resonance, and/or
electron spin resonance. In some embodiments, one or more patients
that have been diagnosed with a respective disease, such as
migraine, may be tested for the one or more biological markers to
associate the one or more patients with one or more of the groups
of patients, and to recommend one or more pharmacological agents
(such as one or more acute pharmacological agents, for example, a
respective family of triptans, and/or one or more preventive
therapies) that may offer improved efficacy relative to other
pharmacological agents for the one or more patients. Such a test or
tests, based on the one or more biological markers, may reduce or
eliminate the current approach of trial and error in searching for
one or more pharmacological agents for patients, such as one or
more effective acute and/or preventive therapies, which results in
delays in patient treatment and additional expense.
[0204] In some embodiments, the information collected during the
data-collection time interval may be analyzed to determine one or
more subgroups within a population of patients, such as the group
of migraine patients mentioned above. The one or more subgroups may
be determined based on the one or more identified association
variables (such as migraine triggers), an efficacy of one or more
pharmacological agents (such as one or more acute and/or preventive
therapies), side effects or adverse reactions to one or more
pharmacological agents, and/or patient symptoms (such as migraine
severity and/or frequency). The subgroups may be determined using
statistical analysis and/or determining a presence or an absence of
the one or more biological markers. In some embodiments, the one or
more subgroups may be used to study drug interactions in a
real-world setting and patient population. In some embodiments, the
one or more subgroups may be indicative of underlying polymorphism
in a genetic basis for a respective disease. Information
corresponding to the one or more subgroups may be sold to a third
party, for example, for use in molecular biology studies of the
respective disease, the development of one or more pharmacological
agents, and/or a management of costs associated with the
disease.
[0205] In an exemplary embodiment, a genetic polymorphism for
migraine may be determined. Migraine is a genetically heterogeneous
(polygenetic) disorder. While there is a strong familial
aggregation of migraine (it runs in families) and there is
increased concordance for the disease in mono-zygote twins over
di-zygote twins, suggesting that it has a significant genetic
component, in part it may be explained by environmental
determinants. Thus, heritability estimates are calculated to be
between 40 and 60%. The complex genetics of migraine
(heterogeneity) may have hampered gene identification. Grouping
migraine patients into one or more subgroups based on identified
migraine triggers may aid in the identification of one or more
genetic bases of and/or in the determination of genetic information
for this disease.
[0206] Additional applications in determining one or more asthma
triggers and/or one or more probable asthma triggers for one or
more patients with asthma, determining one or more drug
interactions in one or more patients with hypertension, and pattern
mapping for one or more patients with diabetes mellitus are
described below. The apparatuses and processes disclosed may also
be used to determine an efficacy of one or more homeopathic
remedies, such as an efficacy of one or more herbs.
[0207] Asthma is a chronic inflammatory condition characterized by
excessive sensitivity of the lungs to various stimuli. As with
migraine patients, many asthma patients are instructed to keep
written patient diaries and to attempt to identify patient-specific
trigger mechanisms. Asthma triggers may be specific to an
individual, such as at least the first individual, or may
correspond to one or more groups of individuals. Asthma triggers
may be cumulative and/or inter-operative. One or more asthma
triggers may be required to trigger an attack in a respective
patient.
[0208] In some embodiments, entry criteria may include that asthma
in the respective patient may be sufficiently well controlled that
asthma attacks are not occurring too often of too infrequently to
preclude determination of triggers. In some embodiments, the subset
of pre-determined questions may be used to collect information for
one or more variables that correspond to one or more potential
asthma triggers. Asthma triggers may include respiratory infections
(such as viral infections or colds), allergies (including pollen,
mold, animal dander, feather, dust, food, and/or cockroaches),
irritating gases (such as cigarette smoke), particles in the air
(indoor and/or outdoor air pollutants, including ozone), activities
(such as exercise and vigorous exercise), behaviors (such as
excitement or stress), and/or environmental conditions (such as
exposure to cold air or a sudden temperature change). For asthma,
the temporal onsets 910 (FIG. 9A) may correspond to onset times
and/or an onset time intervals for one or more asthma attacks,
which are the events. Statistical analysis may determine one or
more statistical relationships between the temporal onsets and
patterns of occurrence of one or more variables and/or one or more
compound variables allowing one or more association variables
(asthma triggers) to be identified. The one or more association
variables may be provided to at least the first individual and/or
at least the second individual in the form of one or more
recommendations and/or one or more reports. The one or more
recommendations may include one or more asthma triggers that at
least the first individual may wish to avoid.
[0209] In some embodiments, the information collected during the
data-collection time interval may include one or more metrics
corresponding to measures of asthma control in at least the first
individual. The one or more metrics may include day and/or night
symptoms (such as wheeze and cough), interventions such as a
quantified use of inhaled bronchodilators (such as a number of
treatments with pharmacological agents such as albuterol) and/or
oral corticosteroid (including a dosage), daytime activity levels,
peak expiratory flow in 1 second, and/or forced expiratory volume
in 1 second. Day symptoms may include if vigorous activity is okay,
if the respective patient can only run briefly, if the respective
patient can only walk, and/or if the respective patient must rest
at home. Night symptoms may include whether it was a good night
(such as the respective patient slept well but there was some
wheeze or cough, or the respective patient was awake briefly with
wheeze or cough) or a bad night (the respective patient was awake
repeatedly). Wheeze may be described as none, briefly, not
troublesome, several times, or continuous. Cough may be described
as none, persistent but not troublesome, interrupted activities
once, or interrupted activities more than once. Peak flow and/or
volume may be measured in the morning (best of three efforts)
and/or the evening (best of 3 efforts).
[0210] Hypertension (high blood pressure) is a multi-factorial
disease. As a consequence, many patients that are treated for
hypertension may be prescribed two or more pharmacological agents
in an attempt to control or regulate the disease. Some patients may
use dozens of drugs concurrently. Such pharmacological agents,
however, many have side effects and there may be interactions
between drugs. It may be difficult for at least the second
individual to determine which pharmacological agent(s) may be
associated with which side effect, and to modify drug choice and
dosage accordingly.
[0211] In some embodiments, the subset of pre-determined questions
may be used to collect information corresponding to variables such
as what pharmacological agents were taken and when, what the
dosages were (time and quantity), side effect symptoms, and/or
blood pressure data. Some information, such as test results
corresponding to side effects of one or more pharmacological
agents, may be provided by and/or collected from at least the
second individual. The events and temporal onsets (including onset
times and/or onset time intervals) may include improved regulation
of hypertension, poorer regulation of hypertension, a reduction in
one or more side effects, and/or an increase in a severity of one
or more side effects. Statistical analysis, including one or more
look-up tables of possible side effects of (discussed further
below) and/or metabolic pathways for one or more pharmacological
agents, may be used to determine the one or more statistical
relationships and identify the one or more association variables.
One or more side effects may be used as one or more additional
inputs 1414 (FIG. 14). One or more recommendations and/or reports
may be provided to at least the first individual and/or at least
the second individual. These may include suggestions on one or more
association variables that may be avoided and/or modified (such as
for behaviors) to improve control of hypertension. The one or more
recommendations and/or reports may include suggestions for
pharmacological agents and/or dosage (time and/or quantity) to
reduce or eliminate one or more side effects and/or to improve
regulation of hypertension.
[0212] Pharmacological agents may include diuretics, beta blockers,
ACE inhibitors, angiotensin II receptor blockers, calcium channel
blockers, alpha blockers, central agonists, peripheral adrenergic
inhibitors, and/or blood vessel dilators. Diuretics may decrease
potassium levels. As a consequence, "potassium sparing"
pharmacological agents such as amiloride, spironolactone or
triamterene may be taken concurrently. Side effects may include
weakness, leg cramps, being tired, gout and/or impotence. In
diabetics, diuretics may change the blood glucose level. This may
be addressed by changing the diuretic, diet, activity insulin type,
insulin dosage, and/or the use of additional pharmacological agents
to change insulin sensitivity. Side effects of beta blockers may
include insomnia, cold hands and feet, tiredness, depression, a
slow heartbeat, symptoms of asthma, and/or impotence. Beta blockers
may also complicate the treatment of diabetes mellitus. Side
effects of ACE inhibitors may include a skin rash, loss of taste, a
chronic dry hacking cough, and/or kidney damage. Side effects of
angiotensin II receptor blockers may include dizziness. Side
effects of calcium channel blockers may include heart palpitations,
swollen ankles, constipation, headache, and/or dizziness. Side
effects of alpha blockers may include a fast heart rate, dizziness,
and/or a drop in blood pressure when the respective patient stands
up. A combination of alpha and beta blockers may result in a drop
in blood pressure when the respective patient stands up. Side
effects of central agonists may include a drop in blood pressure
(including a feeling of weakness and/or fainting) when the
respective patient is in an upright position (standing or walking),
drowsiness, sluggishness, dryness of the mouth, constipation,
fever, anemia, and/or impotence. Side effects of peripheral
adrenergic inhibitors may include a stuffy nose, diarrhea,
heartburn, nightmares, insomnia, depression, diarrhea, impotence,
and/or a drop in blood pressure when the respective patient stands.
Side effects of blood vessel dilators may include headaches,
swelling around the eyes, heart palpitations, aches or pains in the
joints, fluid retention (with a marked weight gain), and/or
excessive hair growth.
[0213] Diabetes mellitus (including insulin dependence) is a
complex disease that is often difficult to manage. Diabetes
mellitus may be classified as one of two types. Type I is thought
to be an auto-immune disorder where the pancreas is no longer able
to produce sufficient insulin. In type II, cellular membranes may
become less sensitive to the effects of insulin. In addition, over
time the resulting elevated blood glucose levels may cause the
pancreas to produce insufficient insulin. Blood glucose level is
dependent on a large number of time varying, interdependent
parameters in several sub-systems in the body. In addition, there
can be secondary effects on the vascular and neurological systems.
Many diabetic patients are instructed to keep written patient diary
and to attempt to identify reasons why the blood glucose level is
high or low (which is referred to as pattern matching).
[0214] In some embodiments, entry criteria for the respective
patient, such as at least the first individual, may include
classification of the disease as early stage, middle stage, or late
stage depending on a severity of secondary effects of this disease,
such as vascular and neurological damage. A level of control of the
disease in the respective patient may be determined to confirm that
conditions such as diabetic coma and insulin shock are either not
present or are unlikely to occur. This may allow reliable
information to be collected during the data-collection time
interval. In some embodiments, the initial survey may include
information from at least the first individual and/or at least the
second individual corresponding to a performance of the liver
and/or the kidneys. The performance of the liver and/or the kidneys
may be in accordance with the classification as early stage, middle
stage, or late stage. In some embodiments, the initial survey may
include a fat percentage, for example, in accordance with a body
mass index. In some embodiments, the initial survey may include
measurements of one or more blood glucose step responses for one or
more types of carbohydrates, fats, protein, and/or minerals.
[0215] The subset of pre-determined questions may be used to
collect information corresponding to variables such as diet,
activity, use of one or more pharmacological agents (which may
include one or more diabetes medicines and/or one or more insulin
types, such as fast acting or slow acting, one or more injection
sites, usage times, and/or quantities), a presence of infection
(such as a measure of body temperature), hydration or dehydration,
hormonal changes (such as those associated with pregnancy, puberty,
menstruation, and/or menopause), dawn phenomenon, behaviors (such
as stress and/or emotion), and/or one or more daily blood glucose
measurements (for example, before meals, 2 hours after meals,
and/or before bedtime). Diet may include a food consumption
history, including timing of meals, types of foods, brands,
quantities, carbohydrates consumed (which may include amounts and
types), fats consumed (which may include amounts and types),
proteins consumed (which may include amounts and types), minerals
consumed (which may include amounts and types), how full the
respective patient was when he or she ate, and/or if a respective
meal was home made. Activity may include an activity level (such as
exercise) and/or an activity history (which may extend over several
days).
[0216] In some embodiments, the events and temporal onsets
(including onset times and/or onset time intervals) correspond to
deviations of blood glucose for at least the first individual
outside of a regulation band, for example, between 80-120 mg/dl or
80-200 mg/dl. Statistical analysis of one or more temporal onsets
and patterns of occurrence of one or more variables and/or one or
more compound variables may be in accordance with a metabolic
model. The metabolic model may include one or more feedback loops,
variable sensitivities, and/or impulse (linear) responses for one
or more types of carbohydrates, fats, proteins, and/or minerals.
The metabolic model may include a model for glucagon, insulin
absorption, digestion (which may include an absorption rate for
different types of carbohydrates, fats, proteins, and/or minerals),
storage in the liver (an insulin sensitivity of liver), and/or a
renal threshold for glucose. The metabolic model may also include
one or more non-linear responses, such as for (peripheral) insulin
sensitivity, glucose level (which is typically linear within
bounds, such as above 70 mg/dl and below 300 mg/dl) and
behavior/activity (such as activity history). The metabolic model
may allow extraneous variables to be excluded in comparisons of
different temporal onsets.
[0217] One or more statistical relationships may allow one or more
association variables, such as one or more variables and/or one or
more compound variables that may be associated with a deviation in
blood glucose level, to be identified. One or more recommendations
and/or one or more reports may be provided to at least the first
individual and/or at least the second individual in accordance with
the one or more identified association variables. These may include
recommendations regarding one or more association variables that
may be avoided and/or modified (such as for behaviors) to improve
control of blood glucose. This may include specific circumstances
(patterns of activity and/or diet) where the recommendations are
applicable. The one or more recommendations and/or reports may
include pharmacological agents and/or dosage (time and/or quantity)
to improve control of blood glucose. Adjustments to insulin, for
example, may include a mean daily dosage and/or day-to-day
variations in dosage about the mean, such as a change in one or
more quantities of insulin and/or one or more fewer or additional
injections. Patterns of activity may include a sequence of
activities over a day, several days, and/or a week. For example,
the sequence of activities may include an exercise history.
[0218] The system and analysis techniques described may also be
used for web-related applications, e.g., to determine the relevant
variables and/or compound variables that internet advertisement may
exhibit in order for users to click on them or pursue them as a
function of time. The advertisement variables may include word
content, graphical properties, colors, animation and/or appearance.
In another embodiment, the system and analysis techniques describe
may be used in network-related applications to determine the
variables and/or compound variables that may lead to the network
going down or experience a fatal crash as a function of time. The
variables may include an amount and a content of network traffic
(registered at nodes, routers, servers, connections, etc.),
caching, package requests posted by users, package requests
received by servers, routing decisions, a number or percentage of
packages that arrive corrupted and/or network delays.
[0219] While embodiments of apparatuses and related methods for
determining one or more association variables have been described,
the apparatuses and related methods may be applied generally to
determine statistical relationships between one or more temporal
onsets corresponding to one or more events and patterns of
occurrence of one or more variables and/or one or more compound
variables in a wide variety of statistical learning problems, in
medicine, psychology, statistics, engineering, applied mathematics
and operations research.
[0220] The foregoing description, for purposes of explanation, used
specific nomenclature to provide a thorough understanding of the
invention. However, it will be apparent to one skilled in the art
that the specific details are not required in order to practice the
invention. The foregoing descriptions of specific embodiments of
the present invention are presented for purposes of illustration
and description. They are not intended to be exhaustive or to limit
the invention to the precise forms disclosed. Obviously many
modifications and variations are possible in view of the above
teachings. The embodiments were chosen and described in order to
best explain the principles of the invention and its practical
applications, the thereby enable others skilled in the art to best
utilize the invention and various embodiments with various
modifications as are suited to the particular use contemplated. It
is intended that the scope of the invention be defined by the
following claims and their equivalents.
* * * * *
References